OPTIMA: CSP #512 - Options in Management With Anti-Retrovirals
Sponsor
US Department of Veterans Affairs (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT00050089
Collaborator
Medical Research Council (Other), Canadian Institutes of Health Research (CIHR) (Other)
368
30
4
83
12.3
0.1
Study Details
Study Description
Brief Summary
This 'pragmatic' trial is a 2X2 open randomized study of patients in advanced HIV disease who have failed on conventional Highly Active Antiretroviral Therapy (HAART) regimens including all three classes of anti-HIV drugs. The first randomization will allocate patients to an intended 3-month antiretroviral drug-free period (ARDFP) or No ARDFP. The second randomization will allocate patients to Mega-ART (5+ drugs) or to Standard-ART (up to 4 drugs). The total study duration is 6.5 years with 5 years of intake and 1.5 year (minimum) of follow-up; median duration of patient follow-up is about 4 years. The target sample size is 390 patients and will provide 75% power to detect a 30% reduction in the hazard rate for the primary endpoint with mega-ART. Sixty-four sites will be participating in the trial--24 VA, 19 UK and 21 Canada.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Primary Hypothesis:
Compared to patients in Standard Antiretroviral Therapy (ART), patients in Mega-ART assuming full compliance, will experience a 30% reduction in the hazard of reaching a clinical endpoint (AIDS event or death).
Secondary Hypotheses:
Time to development of a new, non-HIV related serious adverse event, health related quality of life, the incidence of grade 3 or 4 clinical or laboratory adverse events and changes in virological and immunological markers (CD4 cell count, viral load, resistance profiles) will vary between the different treatment strategies.
Interventions:
Eligible patients will be randomized to one of four treatment strategy arms:
-
No Antiretroviral Drug-Free Period (No ARDFP) and Standard-ART
-
No Antiretroviral Drug-Free Period (No ARDFP) and Mega-ART
-
Antiretroviral Drug-Free Period (ARDFP) and Standard-ART
-
Antiretroviral Drug-Free Period (ARDFP) and Mega-ART
Note: The 'first' randomization will be ARDFP vs No ARDFP. Patients randomized to No ARDFP will receive their 'second' randomization at the same time. However, patients randomized to an Antiretroviral Drug Free Period (ARDFP) will receive their 'second' randomized assignment (Standard or Mega-ART) at the end of the ARDFP.
Note: All Serious Adverse Events were coded using the MedDRA coding dictionary; other (not serious) Adverse Events were collected as part of the study but were not coded using MedDRA or any other standardized coding dictionary.
This is the first trial of a Tri-National collaboration effort between the UK MRC, the Canadian CIHR and the VA CSP. The OPTIMA Trial was reviewed and approved by CSEC on October 12, 2000. The pre-kickoff meeting was held on March 21, 2001 in Washington, DC. The VA study kickoff meeting was held in Dallas, TX on May 16-18, 2001 and the Canadian kickoff was held in Toronto on May 29, 2001. The UK will have individual site initiation. As of October 17, 2005 there have been 357 patients enrolled in OPTIMA, at 64 sites in the three countries (279 in the VA, 41 in Canada and 37 in the UK). To date there are 64 sites actively participating in the study (24 in the VA, 19 in UK and 21 in Canada). Last date of patient follow-up was December 31, 2007.
Study Design
Study Type:
Interventional
Actual Enrollment
:
368 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
CSP #512 - Options in Management With Anti-Retrovirals (OPTIMA), Management of Patients With HIV Infection for Whom First and Second-line Highly Active Anti-Retroviral Therapy Has Failed
Study Start Date
:
Jan 1, 2001
Actual Primary Completion Date
:
Dec 1, 2007
Actual Study Completion Date
:
Dec 1, 2007
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: No ARDFP+Standard-ART No Antiretroviral Drug-Free Period (No ARDFP) and Standard-ART |
Other: No Antiretroviral Drug-Free Period (No ARDFP) vs ARDFP
Continuation or interruption of ART treatment
Drug: Standard ART vs Mega ART
Standard therapy vs Intensified therapy
|
| Active Comparator: No ARDFP+Mega-ART No Antiretroviral Drug-Free Period (No ARDFP) and Mega-ART |
Other: No Antiretroviral Drug-Free Period (No ARDFP) vs ARDFP
Continuation or interruption of ART treatment
Drug: Standard ART vs Mega ART
Standard therapy vs Intensified therapy
|
| Active Comparator: ARDFP+Standard-ART Antiretroviral Drug-Free Period (ARDFP) and Standard-ART |
Other: No Antiretroviral Drug-Free Period (No ARDFP) vs ARDFP
Continuation or interruption of ART treatment
Drug: Standard ART vs Mega ART
Standard therapy vs Intensified therapy
|
| Active Comparator: ARDFP+Mega-ART Antiretroviral Drug-Free Period (ARDFP) and Mega-ART |
Other: No Antiretroviral Drug-Free Period (No ARDFP) vs ARDFP
Continuation or interruption of ART treatment
Drug: Standard ART vs Mega ART
Standard therapy vs Intensified therapy
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With New or Recurrent AIDS Event, or Death [From date of randomization until onset of primary outcome or end of study follow-up (12/31/2007) whichever occured first, up to 6.5 years]
New or recurrent AIDS event or Death were compared between Standard-ART (standard) and Mega-ART (intensification)
- Number of Participants With New or Recurrent AIDS Event, or Death [From date of randomization until onset of primary outcome or end of study follow-up (12/31/2007) whichever occured first, up to 6.5 years]
New or recurrent AIDS event or Death were compared between No ARDFP (continuation) and ARDFP (interruption)
- Number of Participants With New or Recurrent AIDS Event, or Death [From date of randomization until onset of primary outcome or end of study follow-up (12/31/2007) whichever occured first, up to 6.5 years]
New or recurrent AIDS event or Death were compared between No ARDFP (continuation)+Standard-ART (standard), No ARDFP (continuation)+Mega-ART (intensification), ARDFP (interruption)+Standard-ART (standard) and ARDFP (interruption)+Mega-ART (intensification)
Secondary Outcome Measures
- Number of Participants With a New, Non-HIV Related Serious Adverse Event [From date of randomization until onset of secondary outcome or end of study follow-up (12/31/2007) whichever occured first, up to 6.5 years]
New, on-study non-HIV related Serious Adverse events were compared between Standard-ART (standard) and Mega-ART (intensification)
- Number of Participants With New, Non-HIV Related Serious Adverse Event [From date of randomization until onset of secondary outcome or end of study follow-up (12/31/2007) whichever occured first, up to 6.5 years]
New, on-study non-HIV related Serious Adverse events were compared between ARDFP (interruption) and No ARDFP (continuation)
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Ability to provide informed consent
-
Age of 18 years or more
-
Serologic or virologic diagnosis of HIV infection
-
Failure of at least two different multi-drug regimens that include drugs of all 3 classes that the patient can tolerate or laboratory evidence of resistance to drugs in each of the 3 classes
-
Had at least 3 months of current ART and are still on treatment
-
Two most recent results (which can include screening) on current ART of CD4 count less than or equal to 300 cells/mm3 or less than or equal to 15%, and a plasma viral load greater than or equal to 5,000 copies/ml (Roche Amplicor, v1.0), or greater than or equal to 2,500 copies/ml (by bDNA: Bayer v3.0/Chiron v3.0 or PCR:Roche Amplicor Monitor/COBAS v1.5)
Exclusion Criteria:
-
Pregnancy, breast-feeding or planned pregnancy
-
Likelihood of poor protocol follow-up or if Mega-Art is not feasible (due to significant intolerance of many ARV drugs)
-
Serious, uncontrolled major opportunistic infection (OI) within 14 days of screening
-
Likelihood of early death due to non-HIV disease
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Carl T. Hayden VA Medical Center | Phoenix | Arizona | United States | 85012 |
| 2 | VA Medical Center, Long Beach | Long Beach | California | United States | 90822 |
| 3 | VA Palo Alto Health Care System | Palo Alto | California | United States | 94304-1290 |
| 4 | VA San Diego Healthcare System, San Diego | San Diego | California | United States | 92161 |
| 5 | VA Greater Los Angeles Healthcare System, West LA | West Los Angeles | California | United States | 90073 |
| 6 | VA Connecticut Health Care System (West Haven) | West Haven | Connecticut | United States | 06516 |
| 7 | VA Medical Center, DC | Washington | District of Columbia | United States | 20422 |
| 8 | North Florida/South Georgia Veterans Health System | Gainesville | Florida | United States | 32608 |
| 9 | VA Medical Center, Miami | Miami | Florida | United States | 33125 |
| 10 | Bay Pines VAMC (111J) | St. Petersburg | Florida | United States | 33708 |
| 11 | West Palm Beach VA Medical Center | West Palm Beach | Florida | United States | 33410 |
| 12 | Atlanta VA Medical and Rehab Center, Decatur | Decatur | Georgia | United States | 30033 |
| 13 | Jesse Brown VAMC (WestSide Division) | Chicago | Illinois | United States | 60612 |
| 14 | Edward Hines, Jr. VA Hospital | Hines | Illinois | United States | 60141-5000 |
| 15 | VA Maryland Health Care System, Baltimore | Baltimore | Maryland | United States | 21201 |
| 16 | VA Medical Center, Jamaica Plain Campus | Boston | Massachusetts | United States | 02130 |
| 17 | VA Ann Arbor Healthcare System | Ann Arbor | Michigan | United States | 48113 |
| 18 | VA New Jersey Health Care System, East Orange | East Orange | New Jersey | United States | 07018 |
| 19 | VA Medical Center, Bronx | Bronx | New York | United States | 10468 |
| 20 | New York Harbor HCS | New York | New York | United States | 10010 |
| 21 | VA Medical Center, Durham | Durham | North Carolina | United States | 27705 |
| 22 | VA Medical Center, Cincinnati | Cincinnati | Ohio | United States | 45220 |
| 23 | VA Medical Center, Cleveland | Cleveland | Ohio | United States | 44106 |
| 24 | VA Medical Center, Portland | Portland | Oregon | United States | 97201 |
| 25 | VA Medical Center, Philadelphia | Philadelphia | Pennsylvania | United States | 19104 |
| 26 | WJB Dorn Veterans Hospital, Columbia | Columbia | South Carolina | United States | 29209 |
| 27 | VA North Texas Health Care System, Dallas | Dallas | Texas | United States | 75216 |
| 28 | Michael E. DeBakey VA Medical Center (152) | Houston | Texas | United States | 77030 |
| 29 | VA South Texas Health Care System, San Antonio | San Antonio | Texas | United States | 78229 |
| 30 | VA Medical Center, San Juan | San Juan | Puerto Rico | 00921 |
Sponsors and Collaborators
- US Department of Veterans Affairs
- Medical Research Council
- Canadian Institutes of Health Research (CIHR)
Investigators
- Study Chair: Sheldon Brown, VA Medical Center, Bronx
Study Documents (Full-Text)
None provided.More Information
Publications
- Bansback N, Sun H, Guh DP, Li X, Nosyk B, Griffin S, Barnett PG, Anis AH; OPTIMA TEAM. Impact of the recall period on measuring health utilities for acute events. Health Econ. 2008 Dec;17(12):1413-9. doi: 10.1002/hec.1351.
- Bedimo R, Kyriakides T, Brown S, Weidler J, Lie Y, Coakley E, Holodniy M. Predictive value of HIV-1 replication capacity and phenotypic susceptibility scores in antiretroviral treatment-experienced patients. HIV Med. 2012 Jul;13(6):345-51. doi: 10.1111/j.1468-1293.2011.00981.x. Epub 2012 Jan 26.
- Dau B, Ayers D, Singer J, Harrigan PR, Brown S, Kyriakides T, Cameron DW, Angus B, Holodniy M. Connection domain mutations in treatment-experienced patients in the OPTIMA trial. J Acquir Immune Defic Syndr. 2010 Jun;54(2):160-6. doi: 10.1097/QAI.0b013e3181cbd235.
- Desai S, Kyriakides T, Holodniy M, Al-Salman J, Griffith B, Kozal M. Evolution of genotypic resistance algorithms and their impact on the interpretation of clinical trials: an OPTIMA trial substudy. HIV Clin Trials. 2007 Sep-Oct;8(5):293-302.
- Kyriakides TC, Babiker A, Singer J, Cameron W, Schechter MT, Holodniy M, Brown ST, Youle M, Gazzard B; OPTIMA Study Team. An open-label randomized clinical trial of novel therapeutic strategies for HIV-infected patients in whom antiretroviral therapy has failed: rationale and design of the OPTIMA Trial. Control Clin Trials. 2003 Aug;24(4):481-500.
- Kyriakides TC, Babiker A, Singer J, Piaseczny M, Russo J. Study conduct, monitoring and data management in a trinational trial: the OPTIMA model. Clin Trials. 2004;1(3):277-81.
Responsible Party:
US Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00050089
Other Study ID Numbers:
- 512
First Posted:
Nov 22, 2002
Last Update Posted:
Apr 23, 2015
Last Verified:
Apr 1, 2015
Keywords provided by US Department of Veterans Affairs
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | A total of 368 participants were enrolled in the trial: 41 in Canada, 39 in the UK and 288 in the US-VA. |
|---|---|
| Pre-assignment Detail | 339 participants were randomized to factorial design(Canada=41;UK=10;US-VA=288). 29 participants in the UK were enrolled in a protocol-approved option, where they were allowed to select one of the factors and be randomized to the other. All 29 selected the ARDFP vs No ARDFP factor and were randomized to the Standard-ART vs Mega-ART factor. |
| Arm/Group Title | No ARDFP+Standard-ART | No ARDFP+Mega-ART | ARDFP+Standard-ART | ARDFP+Mega-ART |
|---|---|---|---|---|
| Arm/Group Description | No Antiretroviral Drug-Free Period (No ARDFP) and Standard-ART Standard-ART: up to 4 anti-HIV drugs | No Antiretroviral Drug-Free Period (No ARDFP) and Mega-ART Mega-ART: 5 or more anti-HIV drugs | Antiretroviral Drug-Free Period (ARDFP) and Standard-ART Intended duration of ARDFP: 12 week2 Standard-ART: up to 4 anti-HIV drugs | Antiretroviral Drug-Free Period (ARDFP) and Mega-ART Intended duration of ARDFP: 12 weeks Mega-ART: 5 or more anti-HIV drugs |
| Period Title: Overall Study | ||||
| STARTED | 106 | 98 | 86 | 78 |
| Baseline | 91 | 84 | 86 | 78 |
| COMPLETED | 106 | 98 | 86 | 78 |
| NOT COMPLETED | 0 | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | No ARDFP + Standard ART | No ARDFP + Mega ART | ARDFP + Standard ART | ARDFP + Mega ART | Total |
|---|---|---|---|---|---|
| Arm/Group Description | Standard Antiretroviral Treatment regimen | Intensive Antiretroviral Treatment regimen | Antiretroviral Treatment Interruption and Standard ART | Antiretroviral Treatment Interruption and Intensive ART | Total of all reporting groups |
| Overall Participants | 91 | 84 | 86 | 78 | 339 |
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
48.7
(8.99)
|
48.3
(7.92)
|
49.2
(8.1)
|
48.2
(8.58)
|
48.6
(8.39)
|
| Age, Customized (participants) [Number] | |||||
| 31-40 years |
16
17.6%
|
11
13.1%
|
12
14%
|
15
19.2%
|
54
15.9%
|
| 41-50 years |
35
38.5%
|
41
48.8%
|
36
41.9%
|
30
38.5%
|
142
41.9%
|
| 51-60 years |
33
36.3%
|
28
33.3%
|
31
36%
|
28
35.9%
|
120
35.4%
|
| >60 years |
7
7.7%
|
4
4.8%
|
7
8.1%
|
5
6.4%
|
23
6.8%
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
1
1.1%
|
2
2.4%
|
2
2.3%
|
2
2.6%
|
7
2.1%
|
| Male |
90
98.9%
|
82
97.6%
|
84
97.7%
|
76
97.4%
|
332
97.9%
|
| Race/Ethnicity, Customized (participants) [Number] | |||||
| White |
42
46.2%
|
45
53.6%
|
38
44.2%
|
35
44.9%
|
160
47.2%
|
| Black |
41
45.1%
|
30
35.7%
|
36
41.9%
|
31
39.7%
|
138
40.7%
|
| Asian |
1
1.1%
|
0
0%
|
0
0%
|
0
0%
|
1
0.3%
|
| Hispanic |
6
6.6%
|
9
10.7%
|
9
10.5%
|
12
15.4%
|
36
10.6%
|
| Aboriginal |
1
1.1%
|
0
0%
|
1
1.2%
|
0
0%
|
2
0.6%
|
| Other |
0
0%
|
0
0%
|
2
2.3%
|
0
0%
|
2
0.6%
|
| Region of Enrollment (participants) [Number] | |||||
| United States |
77
84.6%
|
71
84.5%
|
73
84.9%
|
67
85.9%
|
288
85%
|
| United Kingdom |
2
2.2%
|
2
2.4%
|
3
3.5%
|
3
3.8%
|
10
2.9%
|
| Canada |
12
13.2%
|
11
13.1%
|
10
11.6%
|
8
10.3%
|
41
12.1%
|
| log10 Viral Load (log10 copies/mL) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [log10 copies/mL] |
4.76
(0.55)
|
4.75
(0.76)
|
4.64
(0.67)
|
4.7
(0.75)
|
4.71
(0.68)
|
| CD4 cells/mm3 (cells/mm^3) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [cells/mm^3] |
136
(112)
|
127
(107)
|
130
(106)
|
127
(106)
|
130
(108)
|
| CD4 level (participants) [Number] | |||||
| CD4 <=100 cells/mm^3 |
38
41.8%
|
38
45.2%
|
36
41.9%
|
33
42.3%
|
145
42.8%
|
| CD4 >100 cells/mm^3 |
53
58.2%
|
46
54.8%
|
50
58.1%
|
45
57.7%
|
194
57.2%
|
| Mode of HIV Infection (participants) [Number] | |||||
| Blood |
12
13.2%
|
7
8.3%
|
8
9.3%
|
7
9%
|
34
10%
|
| Heterosexual |
20
22%
|
19
22.6%
|
22
25.6%
|
19
24.4%
|
80
23.6%
|
| Intravenous Drug Use (IVDU) |
11
12.1%
|
16
19%
|
15
17.4%
|
9
11.5%
|
51
15%
|
| Men who have Sex with Men (MSM) |
42
46.2%
|
37
44%
|
37
43%
|
39
50%
|
155
45.7%
|
| Other |
6
6.6%
|
5
6%
|
2
2.3%
|
4
5.1%
|
17
5%
|
| Unknown |
0
0%
|
0
0%
|
2
2.3%
|
0
0%
|
2
0.6%
|
| AIDS at entry (participants) [Number] | |||||
| Yes |
59
64.8%
|
46
54.8%
|
44
51.2%
|
51
65.4%
|
200
59%
|
| No |
32
35.2%
|
38
45.2%
|
42
48.8%
|
27
34.6%
|
139
41%
|
| Hepatitis B (HBsAg) (participants) [Number] | |||||
| Yes |
10
11%
|
4
4.8%
|
15
17.4%
|
8
10.3%
|
37
10.9%
|
| No |
81
89%
|
80
95.2%
|
71
82.6%
|
70
89.7%
|
302
89.1%
|
| Hepatitis C (Hep C anti-HCV) (participants) [Number] | |||||
| Yes |
17
18.7%
|
21
25%
|
27
31.4%
|
12
15.4%
|
77
22.7%
|
| No |
74
81.3%
|
63
75%
|
59
68.6%
|
66
84.6%
|
262
77.3%
|
| OI medications for prophylaxis (participants) [Number] | |||||
| Anti-PCP |
75
82.4%
|
67
79.8%
|
71
82.6%
|
62
79.5%
|
275
81.1%
|
| Anti-CMV |
2
2.2%
|
0
0%
|
2
2.3%
|
0
0%
|
4
1.2%
|
| Antibacterial |
43
47.3%
|
39
46.4%
|
33
38.4%
|
37
47.4%
|
152
44.8%
|
| Antifungal |
22
24.2%
|
23
27.4%
|
22
25.6%
|
19
24.4%
|
86
25.4%
|
| Concomitant Medications (participants) [Number] | |||||
| Lipid Lowering |
24
26.4%
|
20
23.8%
|
33
38.4%
|
21
26.9%
|
98
28.9%
|
| Other antiviral |
43
47.3%
|
30
35.7%
|
30
34.9%
|
33
42.3%
|
136
40.1%
|
Outcome Measures
| Title | Number of Participants With New or Recurrent AIDS Event, or Death |
|---|---|
| Description | New or recurrent AIDS event or Death were compared between Standard-ART (standard) and Mega-ART (intensification) |
| Time Frame | From date of randomization until onset of primary outcome or end of study follow-up (12/31/2007) whichever occured first, up to 6.5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| This includes participants randomized to Standard-ART or Mega-ART (339 via the 2X2 factorial design and 29 via the UK Option Scheme) |
| Arm/Group Title | Standard-ART | Mega-ART |
|---|---|---|
| Arm/Group Description | This includes participants randomized to Standard-ART (No ARDFP+Standard-ART or ARDFP+Standard-ART) | This includes participants randomized to Mega-ART (No ARDFP+Mega-ART or ARDFP+Mega-ART) |
| Measure Participants | 192 | 176 |
| Number [participants] |
83
91.2%
|
82
97.6%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Standard-ART, Mega-ART |
|---|---|---|
| Comments | Time-to-event (Kaplan-Meier) and stratified log-rank test was used for the comparison. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.69 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.165 | |
| Confidence Interval |
(2-Sided) 95% 0.856 to 1.585 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The comparison was Mega-ART (intensification) vs Standard-ART (standard). | |
| Title | Number of Participants With New or Recurrent AIDS Event, or Death |
|---|---|
| Description | New or recurrent AIDS event or Death were compared between No ARDFP (continuation) and ARDFP (interruption) |
| Time Frame | From date of randomization until onset of primary outcome or end of study follow-up (12/31/2007) whichever occured first, up to 6.5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| This includes participants randomized to No ARDFP or ARDFP (339 via the 2X2 factorial design and 0 via the UK Option Scheme) |
| Arm/Group Title | ARDFP | No ARDFP |
|---|---|---|
| Arm/Group Description | This includes participants randomized to ARDFP (ARDFP+Standard-ART or ARDFP+Mega-ART) | This includes participants randomized to No ARDFP (No ARDFP+Standard-ART or No ARDFP+Mega-ART) |
| Measure Participants | 164 | 175 |
| Number [participants] |
70
76.9%
|
87
103.6%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Standard-ART, Mega-ART |
|---|---|---|
| Comments | Time-to-event (Kaplan-Meier) and stratified log-rank analysis was performed. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.49 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.927 | |
| Confidence Interval |
(2-Sided) 95% 0.674 to 1.275 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The comparison was ARDFP (interruption) vs No ARDFP (continuation) | |
| Title | Number of Participants With New or Recurrent AIDS Event, or Death |
|---|---|
| Description | New or recurrent AIDS event or Death were compared between No ARDFP (continuation)+Standard-ART (standard), No ARDFP (continuation)+Mega-ART (intensification), ARDFP (interruption)+Standard-ART (standard) and ARDFP (interruption)+Mega-ART (intensification) |
| Time Frame | From date of randomization until onset of primary outcome or end of study follow-up (12/31/2007) whichever occured first, up to 6.5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| This includes participants randomized to one of the four interventions (339 via the 2X2 factorial design) |
| Arm/Group Title | No ARDFP + Standard ART | No ARDFP + Mega ART | ARDFP + Standard ART | ARDFP + Mega ART |
|---|---|---|---|---|
| Arm/Group Description | Standard ART regimen, with no prior ART interruption | Intensive ART regimen, with no prior ART interruption | Standard ART regimen following ART interruption | Intensive ART following ART interruption |
| Measure Participants | 91 | 84 | 86 | 78 |
| Number [participants] |
46
50.5%
|
41
48.8%
|
35
40.7%
|
35
44.9%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Standard-ART, Mega-ART, ARDFP + Standard ART, ARDFP + Mega ART |
|---|---|---|
| Comments | Stratified Log-rank test was used to compare the four treatment | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.87 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Title | Number of Participants With a New, Non-HIV Related Serious Adverse Event |
|---|---|
| Description | New, on-study non-HIV related Serious Adverse events were compared between Standard-ART (standard) and Mega-ART (intensification) |
| Time Frame | From date of randomization until onset of secondary outcome or end of study follow-up (12/31/2007) whichever occured first, up to 6.5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Standard-ART | Mega-ART |
|---|---|---|
| Arm/Group Description | This includes participants randomized to Standard-ART (No ARDFP+Standard-ART or ARDFP+Standard-ART) | This includes participants randomized to Mega-ART (No ARDFP+Mega-ART or ARDFP+Mega-ART) |
| Measure Participants | 192 | 176 |
| Number [participants] |
97
106.6%
|
88
104.8%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Standard-ART, Mega-ART |
|---|---|---|
| Comments | Time-to-event (Kaplan-Meier) and stratified log-rank test was used for the comparison | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.92 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.008 | |
| Confidence Interval |
(2-Sided) 95% 0.75 to 1.35 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The comparison was Standard-ART (standard) vs Mega-ART (intensification) | |
| Title | Number of Participants With New, Non-HIV Related Serious Adverse Event |
|---|---|
| Description | New, on-study non-HIV related Serious Adverse events were compared between ARDFP (interruption) and No ARDFP (continuation) |
| Time Frame | From date of randomization until onset of secondary outcome or end of study follow-up (12/31/2007) whichever occured first, up to 6.5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | ARDFP | No ARDFP |
|---|---|---|
| Arm/Group Description | This includes participants randomized to ARDFP (ARDFP+Standard-ART or ARDFP+Mega-ART) | This includes participants randomized to No ARDFP (No ARDFP+Standard-ART or No ARDFP+Mega-ART) |
| Measure Participants | 164 | 175 |
| Number [participants] |
84
92.3%
|
92
109.5%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Standard-ART, Mega-ART |
|---|---|---|
| Comments | Time-to-event (Kaplan-Meier) and stratified log-rank test was used for the comparison. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.68 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.08 | |
| Confidence Interval |
(2-Sided) 95% 0.8 to 1.46 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The comparison was ARDFP (interruption) vs No ARDFP (continuation) of ART | |
Adverse Events
| Time Frame | ||||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | MedDRA was used to code SAE of participants randomized to the 2x2 factorial design (n=339).Hence the number at risk for the four arms reflects only participants enrolled in the 2x2 factorial. Not Serious Adverse events were not coded using MedDRA. | |||||||
| Arm/Group Title | No ARDFP + Standard ART | No ARDFP + Mega ART | ARDFP + Standard ART | ARDFP + Mega ART | ||||
| Arm/Group Description | Standard Antiretroviral Treatment regimen | Intensive Antiretroviral Treatment regimen | Antiretroviral Treatment Interruption and Standard ART | Antiretroviral Treatment Interruption and Intensive ART | ||||
All Cause Mortality |
||||||||
| No ARDFP + Standard ART | No ARDFP + Mega ART | ARDFP + Standard ART | ARDFP + Mega ART | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| No ARDFP + Standard ART | No ARDFP + Mega ART | ARDFP + Standard ART | ARDFP + Mega ART | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 55/91 (60.4%) | 56/84 (66.7%) | 54/86 (62.8%) | 49/78 (62.8%) | ||||
| Blood and lymphatic system disorders | ||||||||
| Acquired methaemoglobinaemia | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 1/86 (1.2%) | 2 | 0/78 (0%) | 0 |
| Anaemia NOS | 5/91 (5.5%) | 7 | 5/84 (6%) | 6 | 6/86 (7%) | 10 | 5/78 (6.4%) | 6 |
| Anaemia of chronic disease | 0/91 (0%) | 0 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 1/78 (1.3%) | 2 |
| Bone marrow depression NOS | 0/91 (0%) | 0 | 1/84 (1.2%) | 2 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Febrile neutropenia | 2/91 (2.2%) | 2 | 1/84 (1.2%) | 1 | 1/86 (1.2%) | 2 | 1/78 (1.3%) | 1 |
| Leukocytosis | 1/91 (1.1%) | 1 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Neutropenia | 2/91 (2.2%) | 2 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Pancytopenia | 1/91 (1.1%) | 1 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Secondary anaemia | 2/91 (2.2%) | 2 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Thrombocytopenia | 0/91 (0%) | 0 | 1/84 (1.2%) | 3 | 1/86 (1.2%) | 2 | 1/78 (1.3%) | 1 |
| Cardiac disorders | ||||||||
| Acute coronary syndrome | 1/91 (1.1%) | 1 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Acute myocardial infarction | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Atrial tachycardia | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Bradycardia NOS | 0/91 (0%) | 0 | 1/84 (1.2%) | 2 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Cardiac aneurysm | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Cardiac arrest | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Cardiac disorder NOS | 0/91 (0%) | 0 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Cardiac failure NOS | 0/91 (0%) | 0 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Cardiac failure congestive | 2/91 (2.2%) | 3 | 3/84 (3.6%) | 3 | 0/86 (0%) | 0 | 1/78 (1.3%) | 2 |
| Cardio-respiratory arrest | 0/91 (0%) | 0 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Cardiomyopathy NOS | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Cardiovascular disorder NOS | 1/91 (1.1%) | 1 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Coronary artery atherosclerosis | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Coronary artery disease NOS | 0/91 (0%) | 0 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Diastolic dysfunction | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 2 |
| Endocarditis NOS | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Myocardial infarction | 2/91 (2.2%) | 2 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 1/78 (1.3%) | 1 |
| Myocardial ischaemia | 0/91 (0%) | 0 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Tachycardia NOS | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Ventricular hypokinesia | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Ear and labyrinth disorders | ||||||||
| Deafness neurosensory | 0/91 (0%) | 0 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Ear pain | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Vertigo | 1/91 (1.1%) | 1 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Endocrine disorders | ||||||||
| Adrenal insufficiency NOS | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Diabetes insipidus | 0/91 (0%) | 0 | 1/84 (1.2%) | 2 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Eye disorders | ||||||||
| Retinitis NOS | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Uveitis NOS | 1/91 (1.1%) | 1 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Vision abnormal NOS | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Gastrointestinal disorders | ||||||||
| Abdominal distension | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Abdominal pain NOS | 4/91 (4.4%) | 4 | 1/84 (1.2%) | 1 | 1/86 (1.2%) | 1 | 1/78 (1.3%) | 1 |
| Abdominal pain lower | 1/91 (1.1%) | 1 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Abdominal pain upper | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Alcoholic pancreatitis | 1/91 (1.1%) | 1 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Anal fissure | 0/91 (0%) | 0 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Ascites | 0/91 (0%) | 0 | 1/84 (1.2%) | 2 | 0/86 (0%) | 0 | 1/78 (1.3%) | 2 |
| Caecitis | 1/91 (1.1%) | 1 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Diarrhoea NOS | 5/91 (5.5%) | 5 | 4/84 (4.8%) | 5 | 4/86 (4.7%) | 4 | 1/78 (1.3%) | 1 |
| Diverticulitis NOS | 1/91 (1.1%) | 1 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Dysphagia | 2/91 (2.2%) | 2 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 1/78 (1.3%) | 1 |
| Gastrointestinal disorder NOS | 1/91 (1.1%) | 1 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Gastrointestinal haemorrhage NOS | 1/91 (1.1%) | 1 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Haemorrhoidal haemorrhage | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Haemorrhoids | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Intestinal perforation NOS | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Intestinal ulcer | 0/91 (0%) | 0 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Lower gastrointestinal haemorrhage | 0/91 (0%) | 0 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Melaena | 1/91 (1.1%) | 1 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Nausea | 0/91 (0%) | 0 | 1/84 (1.2%) | 1 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Oesophageal ulcer | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 2/86 (2.3%) | 2 | 1/78 (1.3%) | 2 |
| Oesophagitis NOS | 2/91 (2.2%) | 2 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Pancreatic pseudocyst | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Pancreatitis NOS | 0/91 (0%) | 0 | 2/84 (2.4%) | 2 | 1/86 (1.2%) | 2 | 1/78 (1.3%) | 2 |
| Pancreatitis acute | 1/91 (1.1%) | 1 | 2/84 (2.4%) | 2 | 0/86 (0%) | 0 | 3/78 (3.8%) | 3 |
| Pancreatitis relapsing | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 2/78 (2.6%) | 5 |
| Perirectal abscess | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Vomiting NOS | 4/91 (4.4%) | 6 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 2/78 (2.6%) | 3 |
| General disorders | ||||||||
| Adverse drug reaction NOS | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 2/78 (2.6%) | 2 |
| Chest pain | 2/91 (2.2%) | 2 | 1/84 (1.2%) | 2 | 3/86 (3.5%) | 3 | 0/78 (0%) | 0 |
| Death NOS | 5/91 (5.5%) | 5 | 0/84 (0%) | 0 | 7/86 (8.1%) | 7 | 6/78 (7.7%) | 6 |
| Drug interaction NOS | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Fall | 2/91 (2.2%) | 2 | 2/84 (2.4%) | 2 | 2/86 (2.3%) | 2 | 0/78 (0%) | 0 |
| Fatigue | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Influenza like illness | 3/91 (3.3%) | 3 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Mucosal inflammation NOS | 0/91 (0%) | 0 | 1/84 (1.2%) | 2 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Multi-organ failure | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Necrosis NOS | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 2 |
| Pain NOS | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Pyrexia | 7/91 (7.7%) | 7 | 1/84 (1.2%) | 4 | 3/86 (3.5%) | 3 | 3/78 (3.8%) | 4 |
| Weakness | 2/91 (2.2%) | 2 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Hepatobiliary disorders | ||||||||
| Bile duct stenosis | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Cholecystitis NOS | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 2 |
| Hepatic disorder NOS | 0/91 (0%) | 0 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Hepatic failure | 1/91 (1.1%) | 1 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Hepatitis NOS | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Hepatitis acute | 1/91 (1.1%) | 1 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Hepatorenal failure | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Jaundice NOS | 1/91 (1.1%) | 1 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Immune system disorders | ||||||||
| Anaphylactic reaction | 1/91 (1.1%) | 1 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Drug hypersensitivity | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 1/78 (1.3%) | 1 |
| Hypersensitivity NOS | 1/91 (1.1%) | 1 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Immune reconstitution syndrome | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Serum sickness | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Infections and infestations | ||||||||
| Abscess NOS | 0/91 (0%) | 0 | 1/84 (1.2%) | 1 | 1/86 (1.2%) | 1 | 1/78 (1.3%) | 2 |
| Abscess limb | 0/91 (0%) | 0 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Acquired immunodeficiency syndrome NOS | 1/91 (1.1%) | 1 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Arterio-venous fistula infection | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 2 |
| Aspergillosis | 1/91 (1.1%) | 2 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Bacteraemia | 0/91 (0%) | 0 | 1/84 (1.2%) | 1 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Bacterial sepsis | 0/91 (0%) | 0 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Bronchitis NOS | 2/91 (2.2%) | 2 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Bronchitis bacterial NOS | 0/91 (0%) | 0 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Bronchopulmonary aspergillosis | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 3 |
| Campylobacter gastroenteritis | 0/91 (0%) | 0 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Carbuncle | 1/91 (1.1%) | 3 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Catheter related infection | 1/91 (1.1%) | 1 | 1/84 (1.2%) | 1 | 2/86 (2.3%) | 2 | 0/78 (0%) | 0 |
| Cellulitis | 3/91 (3.3%) | 3 | 0/84 (0%) | 0 | 4/86 (4.7%) | 4 | 2/78 (2.6%) | 2 |
| Cellulitis orbital | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Central nervous system infection NOS | 1/91 (1.1%) | 1 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Chronic HIV infection | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Clostridial infection NOS | 0/91 (0%) | 0 | 1/84 (1.2%) | 1 | 1/86 (1.2%) | 1 | 1/78 (1.3%) | 1 |
| Colitis pseudomembranous | 4/91 (4.4%) | 4 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Cryptococcosis | 0/91 (0%) | 0 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Cytomegalovirus colitis | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Cytomegalovirus gastroenteritis | 0/91 (0%) | 0 | 2/84 (2.4%) | 2 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Cytomegalovirus infection | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Cytomegalovirus retinitis | 1/91 (1.1%) | 1 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Diarrhoea infectious | 1/91 (1.1%) | 1 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Epidural abscess | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Escherichia urinary tract infection | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| External ear infection NOS | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Eye infection syphilitic | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Fungal infection NOS | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Gastroenteritis NOS | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Gastroenteritis cryptosporidial | 0/91 (0%) | 0 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Gastroenteritis viral NOS | 0/91 (0%) | 0 | 1/84 (1.2%) | 1 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Giardiasis | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Gram-positive bacterial infection | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| HIV wasting syndrome | 0/91 (0%) | 0 | 2/84 (2.4%) | 3 | 1/86 (1.2%) | 1 | 4/78 (5.1%) | 4 |
| Herpes simplex | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 1/78 (1.3%) | 1 |
| Herpes viral infection NOS | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Herpes zoster | 2/91 (2.2%) | 2 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Herpetic stomatitis | 0/91 (0%) | 0 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Histoplasmosis disseminated | 1/91 (1.1%) | 2 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Infected insect bite | 0/91 (0%) | 0 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Infected skin ulcer | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Infection NOS | 0/91 (0%) | 0 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Lobar pneumonia NOS | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Lower respiratory tract infection NOS | 1/91 (1.1%) | 1 | 1/84 (1.2%) | 1 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Lung infection pseudomonal | 1/91 (1.1%) | 2 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Meningitis | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Meningitis bacterial NOS | 1/91 (1.1%) | 2 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Meningitis cryptococcal | 1/91 (1.1%) | 2 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Meningitis viral NOS | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Methicillin-resistant staphylococcal aureus infection | 0/91 (0%) | 0 | 2/84 (2.4%) | 2 | 2/86 (2.3%) | 2 | 3/78 (3.8%) | 4 |
| Mucormycosis | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Mycobacterium avium complex | 2/91 (2.2%) | 2 | 1/84 (1.2%) | 1 | 1/86 (1.2%) | 1 | 2/78 (2.6%) | 3 |
| Necrotising fasciitis NOS | 1/91 (1.1%) | 1 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Nosocomial infection | 1/91 (1.1%) | 1 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Oesophageal candidiasis | 2/91 (2.2%) | 3 | 3/84 (3.6%) | 7 | 1/86 (1.2%) | 1 | 1/78 (1.3%) | 1 |
| Oral candidiasis | 1/91 (1.1%) | 1 | 1/84 (1.2%) | 2 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Oropharyngeal candidiasis | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Osteomyelitis NOS | 0/91 (0%) | 0 | 2/84 (2.4%) | 3 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Otitis media acute NOS | 1/91 (1.1%) | 1 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Parvovirus infection | 1/91 (1.1%) | 1 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Penile abscess | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Perianal abscess | 1/91 (1.1%) | 1 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Periorbital cellulitis | 1/91 (1.1%) | 1 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Peritonsillar abscess | 0/91 (0%) | 0 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Pneumocystis carinii pneumonia | 6/91 (6.6%) | 8 | 7/84 (8.3%) | 8 | 6/86 (7%) | 7 | 5/78 (6.4%) | 8 |
| Pneumonia NOS | 6/91 (6.6%) | 9 | 9/84 (10.7%) | 12 | 9/86 (10.5%) | 11 | 4/78 (5.1%) | 4 |
| Pneumonia bacterial NOS | 1/91 (1.1%) | 1 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 2/78 (2.6%) | 2 |
| Pneumonia staphylococcal | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 1/78 (1.3%) | 1 |
| Pneumonia streptococcal | 0/91 (0%) | 0 | 1/84 (1.2%) | 2 | 1/86 (1.2%) | 1 | 1/78 (1.3%) | 1 |
| Pseudomonas aeruginosa infection NOS | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Pseudomonas infection NOS | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Pyomyositis | 1/91 (1.1%) | 1 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Respiratory tract infection NOS | 2/91 (2.2%) | 2 | 0/84 (0%) | 0 | 2/86 (2.3%) | 2 | 0/78 (0%) | 0 |
| Scrotal abscess | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Sepsis MRSA | 0/91 (0%) | 0 | 2/84 (2.4%) | 2 | 1/86 (1.2%) | 1 | 1/78 (1.3%) | 1 |
| Sepsis NOS | 1/91 (1.1%) | 1 | 2/84 (2.4%) | 2 | 3/86 (3.5%) | 3 | 1/78 (1.3%) | 1 |
| Septic shock | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 2/86 (2.3%) | 2 | 2/78 (2.6%) | 2 |
| Septicaemia gram-positive | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 2/86 (2.3%) | 2 | 0/78 (0%) | 0 |
| Septicaemia pseudomonal | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Septicaemia salmonella | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Sinusitis NOS | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Skin and subcutaneous tissue abscess NOS | 1/91 (1.1%) | 2 | 1/84 (1.2%) | 1 | 1/86 (1.2%) | 1 | 1/78 (1.3%) | 1 |
| Skin fungal infection NOS | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Skin infection NOS | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Staphylococcal abscess | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Staphylococcal bacteraemia | 1/91 (1.1%) | 2 | 1/84 (1.2%) | 1 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Stenotrophomonas infection | 1/91 (1.1%) | 1 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Systemic candida | 1/91 (1.1%) | 1 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Thrombophlebitis septic | 0/91 (0%) | 0 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Toxoplasmosis NOS | 1/91 (1.1%) | 1 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Upper respiratory tract infection NOS | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Upper respiratory tract infection viral NOS | 0/91 (0%) | 0 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Urinary tract infection NOS | 1/91 (1.1%) | 1 | 1/84 (1.2%) | 1 | 1/86 (1.2%) | 2 | 1/78 (1.3%) | 1 |
| Urinary tract infection bacterial | 0/91 (0%) | 0 | 2/84 (2.4%) | 2 | 0/86 (0%) | 0 | 1/78 (1.3%) | 2 |
| Urinary tract infection enterococcal | 0/91 (0%) | 0 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Urinary tract infection fungal | 0/91 (0%) | 0 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Urosepsis | 1/91 (1.1%) | 2 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Viral infection NOS | 1/91 (1.1%) | 1 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Viral rash NOS | 1/91 (1.1%) | 1 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||
| Feeding tube complication | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Gun shot wound | 1/91 (1.1%) | 1 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Head injury | 1/91 (1.1%) | 1 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Limb injury NOS | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Overdose NOS | 0/91 (0%) | 0 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Post procedural haemorrhage | 1/91 (1.1%) | 2 | 0/84 (0%) | 0 | 1/86 (1.2%) | 2 | 0/78 (0%) | 0 |
| Shunt malfunction NOS | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Shunt occlusion | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Tibia fracture | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Wound NOS | 1/91 (1.1%) | 1 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Investigations | ||||||||
| Acid fast stain positive | 0/91 (0%) | 0 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Aspartate aminotransferase increased | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Biopsy NOS | 0/91 (0%) | 0 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Blood creatine phosphokinase increased | 0/91 (0%) | 0 | 1/84 (1.2%) | 2 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Blood creatinine increased | 0/91 (0%) | 0 | 2/84 (2.4%) | 2 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Blood pressure increased | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Laboratory test abnormal NOS | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Liver function tests NOS abnormal | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 2/86 (2.3%) | 2 | 1/78 (1.3%) | 1 |
| Weight decreased | 1/91 (1.1%) | 1 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||||
| Cachexia | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 2/86 (2.3%) | 2 | 1/78 (1.3%) | 2 |
| Dehydration | 2/91 (2.2%) | 3 | 3/84 (3.6%) | 4 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Diabetes mellitus NOS | 1/91 (1.1%) | 1 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 2/78 (2.6%) | 2 |
| Failure to thrive | 1/91 (1.1%) | 1 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 1/78 (1.3%) | 3 |
| Fluid overload | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 5 |
| Hypercalcaemia | 0/91 (0%) | 0 | 1/84 (1.2%) | 2 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Hyperglycaemia NOS | 0/91 (0%) | 0 | 2/84 (2.4%) | 2 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Hyperkalaemia | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Hypertriglyceridaemia | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Hypoglycaemia NOS | 1/91 (1.1%) | 1 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Hypokalaemia | 0/91 (0%) | 0 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Hyponatraemia | 1/91 (1.1%) | 1 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Lactic acidosis | 1/91 (1.1%) | 1 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||||||
| Arthralgia | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Back pain | 1/91 (1.1%) | 1 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Costochondritis | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Haemarthrosis | 1/91 (1.1%) | 1 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Intervertebral disc herniation | 0/91 (0%) | 0 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Muscle spasms | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Musculoskeletal chest pain | 1/91 (1.1%) | 1 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Osteoarthritis NOS | 1/91 (1.1%) | 1 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Rhabdomyolysis | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 2/86 (2.3%) | 2 | 0/78 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
| Anal canal cancer NOS | 1/91 (1.1%) | 1 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Anal cancer stage II | 1/91 (1.1%) | 1 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| B-cell lymphoma NOS | 1/91 (1.1%) | 3 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Bile duct cancer NOS | 1/91 (1.1%) | 1 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Castleman's disease | 0/91 (0%) | 0 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Central nervous system lymphoma | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Diffuse large B-cell lymphoma NOS | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Hepatic neoplasm malignant NOS | 1/91 (1.1%) | 1 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Hodgkin's disease NOS stage III | 1/91 (1.1%) | 1 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Kaposi's sarcoma AIDS related | 1/91 (1.1%) | 1 | 2/84 (2.4%) | 2 | 1/86 (1.2%) | 3 | 1/78 (1.3%) | 1 |
| Laryngeal cancer NOS | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Lung nodule | 1/91 (1.1%) | 1 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Lymphoma NOS | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Papillary tumour of renal pelvis | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Prostate cancer NOS | 2/91 (2.2%) | 2 | 1/84 (1.2%) | 1 | 1/86 (1.2%) | 1 | 2/78 (2.6%) | 2 |
| Prostate cancer metastatic | 0/91 (0%) | 0 | 1/84 (1.2%) | 2 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Rectal cancer NOS | 1/91 (1.1%) | 4 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Squamous cell carcinoma | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| T-cell lymphoma NOS | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Nervous system disorders | ||||||||
| Amyotrophic lateral sclerosis | 0/91 (0%) | 0 | 1/84 (1.2%) | 4 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Aphasia | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Carotid artery stenosis | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Cerebral disorder | 0/91 (0%) | 0 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Cerebrovascular accident | 0/91 (0%) | 0 | 1/84 (1.2%) | 1 | 1/86 (1.2%) | 1 | 2/78 (2.6%) | 2 |
| Cervical radiculopathy | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Convulsions NOS | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 2/78 (2.6%) | 2 |
| Dementia NOS | 2/91 (2.2%) | 2 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Dizziness | 0/91 (0%) | 0 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Dystonia | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Facial palsy | 0/91 (0%) | 0 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Facial paresis | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Grand mal convulsion | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Haemorrhagic stroke | 0/91 (0%) | 0 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Headache NOS | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Loss of consciousness | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Lumbar radiculopathy | 1/91 (1.1%) | 1 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Memory impairment | 1/91 (1.1%) | 1 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Meningitis aseptic | 0/91 (0%) | 0 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Migraine NOS | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Motor dysfunction NOS | 0/91 (0%) | 0 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Myelopathy | 0/91 (0%) | 0 | 1/84 (1.2%) | 2 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Neurological findings abnormal NOS | 0/91 (0%) | 0 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Peripheral neuropathy aggravated | 1/91 (1.1%) | 1 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Status epilepticus | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Subacute combined cord degeneration | 0/91 (0%) | 0 | 1/84 (1.2%) | 2 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Syncope | 3/91 (3.3%) | 4 | 2/84 (2.4%) | 2 | 0/86 (0%) | 0 | 2/78 (2.6%) | 2 |
| Tonic clonic movements | 0/91 (0%) | 0 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Transient ischaemic attack | 0/91 (0%) | 0 | 1/84 (1.2%) | 2 | 0/86 (0%) | 0 | 1/78 (1.3%) | 2 |
| Psychiatric disorders | ||||||||
| Acute psychosis | 1/91 (1.1%) | 1 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Aggression | 1/91 (1.1%) | 1 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Anxiety | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Bipolar I disorder | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Depression | 1/91 (1.1%) | 1 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Depression suicidal | 1/91 (1.1%) | 1 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Drug addiction | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 1/86 (1.2%) | 4 | 0/78 (0%) | 0 |
| Mental status changes | 2/91 (2.2%) | 2 | 2/84 (2.4%) | 2 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Mood disorder NOS | 0/91 (0%) | 0 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Polysubstance dependence | 0/91 (0%) | 0 | 1/84 (1.2%) | 2 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Psychotic disorder NOS | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Suicidal ideation | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Renal and urinary disorders | ||||||||
| Acute pre-renal failure | 0/91 (0%) | 0 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Calculus renal NOS | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Eosinophilic cystitis | 0/91 (0%) | 0 | 1/84 (1.2%) | 2 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Haematuria | 1/91 (1.1%) | 1 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Nephrocalcinosis | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Renal failure NOS | 3/91 (3.3%) | 3 | 2/84 (2.4%) | 3 | 2/86 (2.3%) | 2 | 3/78 (3.8%) | 4 |
| Renal failure acute | 3/91 (3.3%) | 6 | 2/84 (2.4%) | 2 | 0/86 (0%) | 0 | 3/78 (3.8%) | 3 |
| Renal failure acute on chronic | 1/91 (1.1%) | 1 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Renal failure chronic | 2/91 (2.2%) | 2 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Renal impairment NOS | 0/91 (0%) | 0 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Renal tubular necrosis | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Ureteric obstruction | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Urinary retention | 1/91 (1.1%) | 1 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Reproductive system and breast disorders | ||||||||
| Testicular torsion | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Asthma NOS | 0/91 (0%) | 0 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Chronic obstructive airways disease | 1/91 (1.1%) | 1 | 0/84 (0%) | 0 | 2/86 (2.3%) | 2 | 0/78 (0%) | 0 |
| Chronic obstructive airways disease exacerbated | 1/91 (1.1%) | 1 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Dyspnoea NOS | 1/91 (1.1%) | 1 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Epistaxis | 0/91 (0%) | 0 | 1/84 (1.2%) | 1 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Hilar lymphadenopathy | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Lung infiltration NOS | 1/91 (1.1%) | 1 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Pneumonia aspiration | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Pneumonitis NOS | 1/91 (1.1%) | 1 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Pneumothorax NOS | 1/91 (1.1%) | 1 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Pulmonary embolism | 2/91 (2.2%) | 2 | 0/84 (0%) | 0 | 1/86 (1.2%) | 2 | 1/78 (1.3%) | 1 |
| Pulmonary hypertension NOS | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Respiratory failure | 2/91 (2.2%) | 2 | 2/84 (2.4%) | 2 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||||
| Hidradenitis | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 2 |
| Mucocutaneous ulceration | 0/91 (0%) | 0 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Psoriasis | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Rash NOS | 1/91 (1.1%) | 1 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Rash pruritic | 0/91 (0%) | 0 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Social circumstances | ||||||||
| Drug abuser NOS | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Treatment noncompliance | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Surgical and medical procedures | ||||||||
| Arterio-venous fistula operation | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 2 |
| Blood product transfusion | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Cholecystectomy | 0/91 (0%) | 0 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Haemodialysis | 0/91 (0%) | 0 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Hospitalisation | 0/91 (0%) | 0 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Rectal fistula repair | 1/91 (1.1%) | 2 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Stent insertion NOS | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Tooth extraction NOS | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 3 |
| Vascular disorders | ||||||||
| Arterio-venous fistula thrombosis | 0/91 (0%) | 0 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Atherosclerosis | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Deep venous thrombosis NOS | 2/91 (2.2%) | 2 | 0/84 (0%) | 0 | 2/86 (2.3%) | 2 | 2/78 (2.6%) | 2 |
| Haemorrhage NOS | 1/91 (1.1%) | 1 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Hypertension NOS | 1/91 (1.1%) | 1 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Hypertension aggravated | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Hypertensive crisis | 0/91 (0%) | 0 | 1/84 (1.2%) | 1 | 0/86 (0%) | 0 | 0/78 (0%) | 0 |
| Hypotension NOS | 4/91 (4.4%) | 5 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 3/78 (3.8%) | 3 |
| Orthostatic hypotension | 0/91 (0%) | 0 | 2/84 (2.4%) | 2 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
| Vascular pseudoaneurysm | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 0/86 (0%) | 0 | 1/78 (1.3%) | 1 |
| Venous thrombosis deep limb | 0/91 (0%) | 0 | 0/84 (0%) | 0 | 1/86 (1.2%) | 1 | 0/78 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||
| No ARDFP + Standard ART | No ARDFP + Mega ART | ARDFP + Standard ART | ARDFP + Mega ART | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/106 (0%) | 0/98 (0%) | 0/86 (0%) | 0/78 (0%) | ||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Sheldon Brown |
|---|---|
| Organization | VAMC Bronx |
| Phone | (718) 584-9000 ext 6666 |
| sheldon.brown@va.gov |
Responsible Party:
US Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00050089
Other Study ID Numbers:
- 512
First Posted:
Nov 22, 2002
Last Update Posted:
Apr 23, 2015
Last Verified:
Apr 1, 2015