iPrEx: Emtricitabine/Tenofovir Disoproxil Fumarate for HIV Prevention in Men
Study Details
Study Description
Brief Summary
The purpose of this study is to determine whether daily use of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) can prevent HIV infection in men who also receive HIV counseling, condoms, and treatment for other sexually transmitted infections (STIs).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Detailed Description
The Joint United Nations Programme on AIDS estimates that 14,000 persons are newly infected with HIV every day worldwide; one half of these infections occur in people between the ages of 15 and 24. New infections occur despite widespread awareness of the modes of HIV transmission and the protection afforded by condom use. Effective interventions for HIV prevention are urgently needed. This study will evaluate the safety and efficacy of chemoprophylaxis for HIV prevention in men who have sex with men (MSM) who are at high risk for HIV infection despite using condoms, receiving HIV counseling, and receiving treatment for STIs, particularly hepatitis B virus (HBV) infection. A daily combination dose of emtricitabine and tenofovir disoproxil fumarate (FTC/TDF) has been selected for evaluation because it has a well-established safety record in previous studies and was demonstrated to be effective for HIV prevention in primate models. These medications have long half-lives that allow daily dosing and do not have known interactions with hormonal contraception, methadone, or tuberculosis therapies.
Once on the study drug, participants will be followed for a variable length of time, starting within 4 weeks of their screening visit and lasting up to 144 weeks. All participants will be followed for at least 8 weeks after stopping study drug. Participants who are reactive to a Hepatitis B surface antigen (HBsAg) test will be followed for hepatic flares for 16 additional weeks for a total of 24 weeks after stopping study drug. If enrolled in the optional substudy of bone mineral density, fat distribution, and fasting lipids, the participant will be asked to return for one additional visit 24 weeks after stopping study drug. Participants who HIV seroconvert during their participation will also be followed until the end of the study.
All study visits will be at 4 week intervals. At study entry, high risk, HIV uninfected MSM will be randomly assigned to receive either daily FTC/TDF or placebo, in addition to standard HIV counseling, condoms, and sexually transmitted infection (STI) management. The study will closely monitor biological and behavioral safety, including careful analysis of drug resistance, kidney and liver function, and risk behavior.
At the screening visit, participants will undergo HIV antibody and HBV testing, a medical history, a medical exam, blood and urine collection, risk behavior assessment, and STI testing. At study entry, participants will be given study medication; tested for HCV; and offered the HBV vaccine, if applicable. At all study visits, there will be HIV antibody testing, pill counts, adherence checks, study medication distribution, HIV counseling, and condom distribution. A medical history and blood will be taken on selected visits, along with STI testing and treatment if needed. Testing and treatment of STIs will be provided at no cost to the participant.
All study participants will be encouraged to join a substudy that will assess interactions between HBV infection, bone mineral density and fat distribution, and immune function. If enrolled in the substudy, the participant will be asked to return for one additional visit 24 weeks after stopping the study medication. All participants in the substudy will undergo dual energy x-ray absorptiometry (DEXA) scans, and HIV infected participants will undergo additional blood collection.
Sites will have the option of participating in the following four substudies:
The Hair Substudy: Participants who are receiving FTC/TDF will be eligible to enroll. At each 12-week follow-up study visit, hair samples will be collected and questionnaires will be completed.
The Urine Substudy: For all participants who elect to enroll in this substudy, additional testing will occur on blood and urine samples collected at each 24-week follow-up visit. An additional urine collection will occur 8 weeks after participants stop receiving FTC/TDF.
The Semen Substudy: Participants who seroconvert during the study may elect to participate in this substudy. One semen sample will be collected at participants' next study visit when plasma viral load testing is performed.
The Gonorrhea and Chlamydia Substudy: Participants in this substudy will undergo rectal and oropharyngeal swab procedures and urine collection at the 24-week study visit.
After the randomized phase ends, if the daily oral FTC/TDF arm is shown to be beneficial and safe, participants will be given the option of participating in an open label extension phase. During this extension phase, study participants will receive daily oral open-label FTC/TDF, in addition to standard counseling, condoms, and STI management.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: TDF/FTC Drug. Daily oral tablet of co-formulated 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate (TDF/FTC). |
Drug: daily TDF/FTC
daily oral medication
Other Names:
|
Placebo Comparator: Placebo Drug. Daily oral placebo |
Drug: Placebo
daily oral medication
|
Outcome Measures
Primary Outcome Measures
- HIV Seroconversion [Monthly follow-up through a median of 1.2 years]
Confirmed HIV infection
- Grade 1 or Higher Creatinine Toxicity [Duration of follow-up, median 1.2 years]
Creatinine which reach grade 1 (mild, 1.1 to 1.3 local upper limit of normal) or higher by the US Division of AIDS grading table (version 1) or a 50% increase in creatinine from the baseline value. The DAIDS table can be found at https://rsc.tech-res.com/docs/default-source/safety/table_for_grading_severity_of_adult_pediatric_adverse_events.pdf
- Grade 3 or Higher Phosphorous Toxicity [The entire follow-up period, median 1.2 years]
Grade 3 or higher phosphorous toxicity (hypophosphatemia) by the Division of AIDS Grading Table (severe, level at or below 1.9 mg/dL)
- Grade 2, 3, or 4 Laboratory Adverse Events [Entire follow-up, median 1.2 years]
Number of participants with at least one Grade 2, 3, or 4 laboratory adverse events (moderate, severe of life threatening based one the US Division of AIDS Grading of adverse events, version 1.0). The table can be found at https://rsc.tech-res.com/docs/default-source/safety/table_for_grading_severity_of_adult_pediatric_adverse_events.pdf
- Grade 2, 3, or 4 Clinical Adverse Events [Entire follow-up, median 1.2 years]
Number of participants with at least 1 Grade 2, 3, or 4 clinical adverse events (moderate, severe of life threatening based one the US Division of AIDS Grading of adverse events, version 1.0). The table can be found at https://rsc.tech-res.com/docs/default-source/safety/table_for_grading_severity_of_adult_pediatric_adverse_events.pdf
Secondary Outcome Measures
- Hepatitis Flares Among Hepatitis B Virus (HBV) Infected Persons During and After Chemoprophylaxis [Quarterly lab tests through a median follow-up of 1.2 years]
A hepatic flare is defined as an increase in alanine transaminase or aspartate transaminase to >5 fold upper limit of normal at any visit, or an increase to >2.5 fold upper limit of normal for 3 months, within 24 weeks of permanently stopping study drug. More details in https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4752387/
- Percentage Change in Bone Mineral Density [baseline and week 24.]
% Change from baseline in bone mineral density (100 * [(value at 24 weeks- value at baseline)/ (value at baseline)]) in in hip and L1-L4 spine by dual-energy x-ray absorptiometry
- Percentage Change in Body Fat [Baseline and Week 24]
Percentage Change (100 * [(value at 24 weeks- value at baseline)/ (value at baseline)]) in Body Fat from Baseline by dual-energy x-ray absorptiometry
- Percentage Change in Fasting Triglycerides [Baseline and Week 24]
Percentage Change (Percentage Change (100 * [(value at 24 weeks- value at baseline)/ (value at baseline)]) in Triglycerides from Baseline from a fasting sample.
- Percent Change in Total Cholesterol [Baseline and Week 24]
Percent change (100 * [(value at 24 weeks- value at baseline)/ (value at baseline)]) in fasting total cholesterol from baseline
- Viral Load Among HIV Infected Participants [At the time closest to HIV detection]
HIV-RNA in log10 units among HIV infected participants at the time closest to HIV detection
- Among HIV Infected Participants Drug Resistance [at the time of HIV acquisition]
Genotypic resistance by clinical assays among the seroconverters from baseline to the end of the study treatment period
- CD4 Count Among HIV Infected Participants [at the time infection was detected]
CD4 cell count for HIV infected participants during the trial
- Proportion of Missed Doses by Pill Count [At 24 weeks]
Estimated proportion of missed doses by pill count (assuming pills taken in unreturned bottles)
- Percentage of Missed Doses by Estimate During CASI Interview [Week 24]
Percentage of missed doses by estimate during computer assisted structured interview
- Number of Condomless Sexual Partners With HIV Positive or Unknown Status [At 24 weeks]
Participants self-report of the number of sexual partners with HIV positive or unknown status in the previous 12 weeks with whom they had condomless anal sex
- Total Number of Sexual Partners [24 weeks]
Self-reported total number of sexual partners in the previous 12 weeks.
- Condomless Receptive Anal Intercourse in the Previous 12 Weeks With Any Partners Regardless of Status. [At 24 weeks]
Self-reported condomless receptive anal intercourse in the previous 12 weeks with any partners regardless of status.
- Incidence of Confirmed Syphilis During Follow-Up [All Follow-Up median of 1.2 years of follow-up]
Number of participants who have at least 1 confirmed syphilis infection during the study
- Incidence of HSV-2 During the Follow-up Period [Total study follow-up, a median of 1.2 years]
Incidence of HSV-2 during the follow-up period among those HIV-2 negative at baseline
- Diagnosis of Gonorrhea During the Follow-up Period [All of follow-up period, median of 1.2 years]
Diagnosis of gonorrhea during the follow-up period by PCR
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male sex (at birth)
-
HIV uninfected
-
Age having reached the local age of consent
-
High risk for HIV infection including any of the following: 1) No condom use during anal intercourse with a male HIV-positive partner or a male partner of unknown HIV status during the last 6 months; (2) anal intercourse with more than 3 male sex partners during the last 6 months; (3) exchange of money, gifts, shelter, or drugs for anal sex with a male partner during the last 6 months; (4) sex with a male partner and STI diagnosis during the last 6 months or at screening, or (5) sexual partner of an HIV-infected man with whom condoms are not consistently used in the last 6 months.
-
Able to provide a street address of residence for themselves and one personal contact who would know their whereabouts during the study period
-
Healthy enough to work, as indicated by score of 80 or greater on the Karnofsky scale
-
Certain laboratory values
-
A urine dipstick with a negative or trace result for both glucose and protein within 28 days of enrollment.
-
Ability to understand and local language for which an informed consent form has been approved by a local IRB and registered with the study sponsor.
Inclusion Criteria for Open-Label Extension:
-
Participated in a randomized, placebo-controlled, PrEP trail
-
Has been unblinded
-
Has provided informed consent
Exclusion Criteria:
-
Previously diagnosed active and serious infections, including tuberculosis infection, osteomyelitis, or infections requiring parenteral antibiotic therapy
-
Active clinically significant medical problems including heart disease (e.g., symptoms of ischemia, congestive heart failure, arrhythmia), lung disease (steroid-dependent chronic obstructive pulmonary disease), diabetes requiring hypoglycemic medication, or previously diagnosed cancer expected to require further treatment
-
Acute HBV infection at the screening visit or presence of treatment indications for hepatitis B based on local practice standards; or clinical signs of hepatic cirrhosis
-
History of pathological bone fractures not related to trauma
-
Receiving ongoing therapy with certain HIV/AIDS-related medications or other medications as determined by the investigator
-
Definitely or possibly received an anti-HIV vaccine while participating in a blinded clinical trial
-
Current alcohol or drug use that, in the opinion of the investigator, may interfere with the study
-
Current participation in a clinical trial or cohort study other than sub-studies of this protocol
-
Any condition at enrollment that, in the opinion of the investigator, would make participation in the study unsafe or would interfere with the study
-
Sites may utilize additional criteria that restrict enrollment to a subset of people who meet the protocol-defined enrollment criteria.
Exclusion Criteria for Open-Label Extension:
- Site leadership believes participant will have difficulty completing requirements
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | San Francisco Dept. of Public Health iPrEx CRS | San Francisco | California | United States | 94102 |
2 | Stroger Hospital of Cook County/Core Center IPREX CRS | Chicago | Illinois | United States | 60612 |
3 | Fenway Community Health iPrEx CRS | Boston | Massachusetts | United States | 02215 |
4 | IPEC/FIOCRUZ iPrEx CRS | Rio de Janeiro | Brazil | 21040-900 | |
5 | Projeto Praca Onze, Universidade Federal do Rio de Janeiro iPrEx CRS | Rio de Janeiro | Brazil | 21941.590 | |
6 | Universidade de Sao Paulo iPrEx CRS | Sao Paulo | Brazil | 05403 | |
7 | Fundación Ecuatoriana Equidad, Guayaquil, iPrEx CRS | Guayaquil | Guayas | Ecuador | |
8 | Asociación Civil Selva Amazónica, Iquitos, iPrEx CRS | Iquitos | Maynas | Peru | |
9 | Investigaciones Médicas en Salud (INMENSA), Lince, iPrEx CRS | Lima | Peru | ||
10 | Desmond Tutu HIV Ctr. iPrEx CRS | Cape Town | South Africa | 7925 | |
11 | Research Institute for Health Sciences iPrEx CRS | Chiang Mai | Thailand | 50200 |
Sponsors and Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Bill and Melinda Gates Foundation
Investigators
- Principal Investigator: Robert M. Grant, MD, MPH, J. David Gladstone Institutes, University of California San Francisco
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- CO-US-104-0288
- 10445
- 1U01AI064002
- iPrEx
- NCT00350324
Study Results
Participant Flow
Recruitment Details | The study recruited HIV uninfected participants whose sexual practices put them at risk for HIV infection. They were recruited from community clinics. |
---|---|
Pre-assignment Detail |
Arm/Group Title | TDF/FTC | Placebo |
---|---|---|
Arm/Group Description | Daily oral emtricitabine/tenofovir disoproxil fumarate Emtricitabine/tenofovir disoproxil fumarate: Fixed-dose coformulation of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate | Daily oral placebo Placebo: Placebo for emtricitabine/tenofovir disoproxil fumarate |
Period Title: Overall Study | ||
STARTED | 1251 | 1248 |
COMPLETED | 942 | 953 |
NOT COMPLETED | 309 | 295 |
Baseline Characteristics
Arm/Group Title | TDF/FTC | Placebo | Total |
---|---|---|---|
Arm/Group Description | Daily oral emtricitabine/tenofovir disoproxil fumarate Emtricitabine/tenofovir disoproxil fumarate: Fixed-dose coformulation of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate | Daily oral placebo Placebo: Placebo for emtricitabine/tenofovir disoproxil fumarate | Total of all reporting groups |
Overall Participants | 1251 | 1248 | 2499 |
Age (Count of Participants) | |||
<=18 years |
92
7.4%
|
101
8.1%
|
193
7.7%
|
Between 18 and 65 years |
1158
92.6%
|
1147
91.9%
|
2305
92.2%
|
>=65 years |
1
0.1%
|
0
0%
|
1
0%
|
Age (years) [Median (Full Range) ] | |||
Median (Full Range) [years] |
25
|
24
|
24
|
Sex/Gender, Customized (Count of Participants) | |||
Male Sex at Birth. Identify Trans |
155
12.4%
|
155
12.4%
|
310
12.4%
|
Male Sex at Birth. Identify Female |
15
1.2%
|
14
1.1%
|
29
1.2%
|
Male Sex at Birth. Identify Male |
1081
86.4%
|
1079
86.5%
|
2160
86.4%
|
Region of Enrollment (participants) [Number] | |||
Ecuador |
150
12%
|
150
12%
|
300
12%
|
United States |
113
9%
|
114
9.1%
|
227
9.1%
|
Brazil |
186
14.9%
|
184
14.7%
|
370
14.8%
|
South Africa |
45
3.6%
|
43
3.4%
|
88
3.5%
|
Thailand |
57
4.6%
|
57
4.6%
|
114
4.6%
|
Peru |
700
56%
|
700
56.1%
|
1400
56%
|
Outcome Measures
Title | HIV Seroconversion |
---|---|
Description | Confirmed HIV infection |
Time Frame | Monthly follow-up through a median of 1.2 years |
Outcome Measure Data
Analysis Population Description |
---|
Excludes participants who were HIV+ at enrollment (2 TDF/FTC, 8 Placebo) and those with no follow-up HIV test (25 TDF/FTC and 22 Placebo). |
Arm/Group Title | TDF/FTC | Placebo |
---|---|---|
Arm/Group Description | Daily oral emtricitabine/tenofovir disoproxil fumarate Emtricitabine/tenofovir disoproxil fumarate: Fixed-dose coformulation of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate | Daily oral placebo Placebo: Placebo for emtricitabine/tenofovir disoproxil fumarate |
Measure Participants | 1224 | 1218 |
Count of Participants [Participants] |
48
3.8%
|
83
6.7%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | TDF/FTC, Placebo |
---|---|---|
Comments | Primary null hypothesis: Relative hazard of 0.7 or less. Secondary null hypothesis: Relative hazard of 1.0 or less. | |
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.002 |
Comments | secondary p-value given. | |
Method | Log Rank | |
Comments | stratified by site | |
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 0.577 | |
Confidence Interval |
(2-Sided) 95% .404 to .824 |
|
Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.105 |
|
Estimation Comments | Efron correction for ties. Placebo is reference. Results typically quoted as efficacy = 100*(1-HR) |
Title | Grade 1 or Higher Creatinine Toxicity |
---|---|
Description | Creatinine which reach grade 1 (mild, 1.1 to 1.3 local upper limit of normal) or higher by the US Division of AIDS grading table (version 1) or a 50% increase in creatinine from the baseline value. The DAIDS table can be found at https://rsc.tech-res.com/docs/default-source/safety/table_for_grading_severity_of_adult_pediatric_adverse_events.pdf |
Time Frame | Duration of follow-up, median 1.2 years |
Outcome Measure Data
Analysis Population Description |
---|
All randomized participants which at least 1 follow-up creatinine value |
Arm/Group Title | TDF/FTC | Placebo |
---|---|---|
Arm/Group Description | Daily oral emtricitabine/tenofovir disoproxil fumarate | Daily oral placebo |
Measure Participants | 1216 | 1217 |
Count of Participants [Participants] |
32
2.6%
|
24
1.9%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | TDF/FTC, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.28 |
Comments | p-value is not adjusted for multiple comparisons, a priori threshold for statistical significance was p < 0.05 | |
Method | Fisher Exact | |
Comments | ||
Method of Estimation | Estimation Parameter | Risk Ratio (RR) |
Estimated Value | 1.33 | |
Confidence Interval |
(2-Sided) 95% 0.79 to 2.25 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | ||
Other Statistical Analysis | Extensive analysis and methods published in https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3966916/ |
Title | Grade 3 or Higher Phosphorous Toxicity |
---|---|
Description | Grade 3 or higher phosphorous toxicity (hypophosphatemia) by the Division of AIDS Grading Table (severe, level at or below 1.9 mg/dL) |
Time Frame | The entire follow-up period, median 1.2 years |
Outcome Measure Data
Analysis Population Description |
---|
All participants with at least 1 follow-up phosphorus value |
Arm/Group Title | TDF/FTC | Placebo |
---|---|---|
Arm/Group Description | Daily oral emtricitabine/tenofovir disoproxil fumarate | Daily oral placebo |
Measure Participants | 1225 | 1226 |
Count of Participants [Participants] |
13
1%
|
10
0.8%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | TDF/FTC, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.54 |
Comments | ||
Method | Fisher Exact | |
Comments | ||
Method of Estimation | Estimation Parameter | Risk Ratio (RR) |
Estimated Value | 1.3 | |
Confidence Interval |
(2-Sided) 95% .57 to 2.96 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Grade 2, 3, or 4 Laboratory Adverse Events |
---|---|
Description | Number of participants with at least one Grade 2, 3, or 4 laboratory adverse events (moderate, severe of life threatening based one the US Division of AIDS Grading of adverse events, version 1.0). The table can be found at https://rsc.tech-res.com/docs/default-source/safety/table_for_grading_severity_of_adult_pediatric_adverse_events.pdf |
Time Frame | Entire follow-up, median 1.2 years |
Outcome Measure Data
Analysis Population Description |
---|
At participants with at least one visit with laboratory values post-baseline |
Arm/Group Title | TDF/FTC | Placebo |
---|---|---|
Arm/Group Description | Daily oral emtricitabine/tenofovir disoproxil fumarate | Daily oral placebo |
Measure Participants | 1229 | 1226 |
Count of Participants [Participants] |
70
5.6%
|
79
6.3%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | TDF/FTC, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.50 |
Comments | ||
Method | Log Rank | |
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 0.89 | |
Confidence Interval |
(2-Sided) 95% 0.65 to 1.23 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Grade 2, 3, or 4 Clinical Adverse Events |
---|---|
Description | Number of participants with at least 1 Grade 2, 3, or 4 clinical adverse events (moderate, severe of life threatening based one the US Division of AIDS Grading of adverse events, version 1.0). The table can be found at https://rsc.tech-res.com/docs/default-source/safety/table_for_grading_severity_of_adult_pediatric_adverse_events.pdf |
Time Frame | Entire follow-up, median 1.2 years |
Outcome Measure Data
Analysis Population Description |
---|
At participants with at least one follow-up visit |
Arm/Group Title | TDF/FTC | Placebo |
---|---|---|
Arm/Group Description | Daily oral emtricitabine/tenofovir disoproxil fumarate | Daily oral placebo |
Measure Participants | 1226 | 1230 |
Count of Participants [Participants] |
157
12.5%
|
162
13%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | TDF/FTC, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.92 |
Comments | ||
Method | Log Rank | |
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 0.99 | |
Confidence Interval |
(2-Sided) 95% 0.79 to 1.23 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Hepatitis Flares Among Hepatitis B Virus (HBV) Infected Persons During and After Chemoprophylaxis |
---|---|
Description | A hepatic flare is defined as an increase in alanine transaminase or aspartate transaminase to >5 fold upper limit of normal at any visit, or an increase to >2.5 fold upper limit of normal for 3 months, within 24 weeks of permanently stopping study drug. More details in https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4752387/ |
Time Frame | Quarterly lab tests through a median follow-up of 1.2 years |
Outcome Measure Data
Analysis Population Description |
---|
Those with chronic active hepatitis B at enrollment. |
Arm/Group Title | TDF/FTC | Placebo |
---|---|---|
Arm/Group Description | Daily oral emtricitabine/tenofovir disoproxil fumarate Emtricitabine/tenofovir disoproxil fumarate: Fixed-dose coformulation of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate | Daily oral placebo Placebo: Placebo for emtricitabine/tenofovir disoproxil fumarate |
Measure Participants | 6 | 6 |
Count of Participants [Participants] |
0
0%
|
0
0%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | TDF/FTC, Placebo |
---|---|---|
Comments | Null hypothesis of no difference | |
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 1.00 |
Comments | ||
Method | Fisher Exact | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | TDF/FTC, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | Desc | |
Statistical Test of Hypothesis | p-Value | 1.00 |
Comments | ||
Method | Fisher Exact | |
Comments | ||
Method of Estimation | Estimation Parameter | Risk Difference (RD) |
Estimated Value | 0.00 | |
Confidence Interval |
(2-Sided) % to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Percentage Change in Bone Mineral Density |
---|---|
Description | % Change from baseline in bone mineral density (100 * [(value at 24 weeks- value at baseline)/ (value at baseline)]) in in hip and L1-L4 spine by dual-energy x-ray absorptiometry |
Time Frame | baseline and week 24. |
Outcome Measure Data
Analysis Population Description |
---|
Participants confirmed to be HIV negative at enrollment who consented to participate in the metabolic substudy. Full details in https://www.ncbi.nlm.nih.gov/pmc/articles/pmid/25908682/ |
Arm/Group Title | TDF/FTC | Placebo |
---|---|---|
Arm/Group Description | Daily oral emtricitabine/tenofovir disoproxil fumarate Emtricitabine/tenofovir disoproxil fumarate: Fixed-dose coformulation of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate | Daily oral placebo Placebo: Placebo for emtricitabine/tenofovir disoproxil fumarate |
Measure Participants | 210 | 211 |
L1-L4 Spine bone mineral density |
-0.59
(0.21)
|
0.32
(0.21)
|
Hip bone mineral density |
-0.34
(0.16)
|
0.29
(0.16)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | TDF/FTC, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.001 |
Comments | < 0.05 for statistical significance. no adjustment for multiple comparisons | |
Method | Mixed Models Analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Net) |
Estimated Value | -.91 | |
Confidence Interval |
(2-Sided) % to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Percentage Change in Body Fat |
---|---|
Description | Percentage Change (100 * [(value at 24 weeks- value at baseline)/ (value at baseline)]) in Body Fat from Baseline by dual-energy x-ray absorptiometry |
Time Frame | Baseline and Week 24 |
Outcome Measure Data
Analysis Population Description |
---|
All participants in the body composition substudy who made a week 24 body scan |
Arm/Group Title | TDF/FTC | Placebo |
---|---|---|
Arm/Group Description | Daily oral emtricitabine/tenofovir disoproxil fumarate | Daily oral placebo |
Measure Participants | 210 | 211 |
Median (Standard Error) [percent change from baseline] |
0.0
(1.0)
|
3.8
(1.0)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | TDF/FTC, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.009 |
Comments | ||
Method | median regression | |
Comments | ||
Method of Estimation | Estimation Parameter | Median Difference (Net) |
Estimated Value | -3.8 | |
Confidence Interval |
(2-Sided) 95% -6.6 to -0.95 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Percentage Change in Fasting Triglycerides |
---|---|
Description | Percentage Change (Percentage Change (100 * [(value at 24 weeks- value at baseline)/ (value at baseline)]) in Triglycerides from Baseline from a fasting sample. |
Time Frame | Baseline and Week 24 |
Outcome Measure Data
Analysis Population Description |
---|
All participants in the metabolic substudy with a week 24 fast triglyceride value |
Arm/Group Title | TDF/FTC | Placebo |
---|---|---|
Arm/Group Description | Daily oral emtricitabine/tenofovir disoproxil fumarate | Daily oral placebo |
Measure Participants | 199 | 194 |
Median (Standard Error) [percent change from baseline] |
0.0
(3.3)
|
0.0
(3.4)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | TDF/FTC, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 1.00 |
Comments | ||
Method | median regression | |
Comments | ||
Method of Estimation | Estimation Parameter | Median Difference (Net) |
Estimated Value | 0.0 | |
Confidence Interval |
(2-Sided) 95% -9.3 to 9.3 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Percent Change in Total Cholesterol |
---|---|
Description | Percent change (100 * [(value at 24 weeks- value at baseline)/ (value at baseline)]) in fasting total cholesterol from baseline |
Time Frame | Baseline and Week 24 |
Outcome Measure Data
Analysis Population Description |
---|
All participants in the metabolic substudy with a week 24 fasting cholesterol |
Arm/Group Title | TDF/FTC | Placebo |
---|---|---|
Arm/Group Description | Daily oral emtricitabine/tenofovir disoproxil fumarate | Daily oral placebo |
Measure Participants | 199 | 194 |
Median (Standard Error) [percent change from baseline] |
-3.2
(1.2)
|
-1.1
(1.2)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | TDF/FTC, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.19 |
Comments | ||
Method | median regression | |
Comments | ||
Method of Estimation | Estimation Parameter | Median Difference (Net) |
Estimated Value | -2.2 | |
Confidence Interval |
(2-Sided) 95% -5.5 to 1.1 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Viral Load Among HIV Infected Participants |
---|---|
Description | HIV-RNA in log10 units among HIV infected participants at the time closest to HIV detection |
Time Frame | At the time closest to HIV detection |
Outcome Measure Data
Analysis Population Description |
---|
All HIV infections detected during the study including prior to, during and after study treatment |
Arm/Group Title | TDF/FTC | Placebo |
---|---|---|
Arm/Group Description | Daily oral emtricitabine/tenofovir disoproxil fumarate | Daily oral placebo |
Measure Participants | 54 | 93 |
Mean (Standard Error) [log RNA copies per ml] |
5.2
(0.11)
|
5.1
(0.08)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | TDF/FTC, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.56 |
Comments | ||
Method | t-test, 2 sided | |
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Net) |
Estimated Value | 0.08 | |
Confidence Interval |
(2-Sided) 95% -.18 to 0.33 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Among HIV Infected Participants Drug Resistance |
---|---|
Description | Genotypic resistance by clinical assays among the seroconverters from baseline to the end of the study treatment period |
Time Frame | at the time of HIV acquisition |
Outcome Measure Data
Analysis Population Description |
---|
There were 2 TDF/FTC seroconversions at enrollment and 48 during follow-up. There were 8 Placebo seroconversions at enrollment and 83 during follow-up. |
Arm/Group Title | TDF/FTC | Placebo |
---|---|---|
Arm/Group Description | Daily oral emtricitabine/tenofovir disoproxil fumarate Emtricitabine/tenofovir disoproxil fumarate: Fixed-dose coformulation of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate | Daily oral placebo Placebo: Placebo for emtricitabine/tenofovir disoproxil fumarate |
Measure Participants | 50 | 91 |
Infected at Enrollment (prior to randomization) |
2
0.2%
|
1
0.1%
|
Infected after Randomization |
0
0%
|
0
0%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | TDF/FTC, Placebo |
---|---|---|
Comments | Null hypothesis is the proportion of mutations is identical. | |
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 1.00 |
Comments | ||
Method | Fisher Exact | |
Comments | ||
Method of Estimation | Estimation Parameter | Risk Ratio (RR) |
Estimated Value | 1.00 | |
Confidence Interval |
(2-Sided) % to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | ||
Other Statistical Analysis | Detailed resistance data is found at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4176446/ |
Title | CD4 Count Among HIV Infected Participants |
---|---|
Description | CD4 cell count for HIV infected participants during the trial |
Time Frame | at the time infection was detected |
Outcome Measure Data
Analysis Population Description |
---|
HIV infected participants during the trial including those HIV+ at baseline |
Arm/Group Title | TDF/FTC | Placebo |
---|---|---|
Arm/Group Description | Daily oral emtricitabine/tenofovir disoproxil fumarate | Daily oral placebo |
Measure Participants | 51 | 87 |
Mean (95% Confidence Interval) [cells per cubic mm] |
495
|
502
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | TDF/FTC, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.32 |
Comments | ||
Method | Mixed Models Analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Net) |
Estimated Value | -7 | |
Confidence Interval |
(2-Sided) 95% -69 to 54 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Proportion of Missed Doses by Pill Count |
---|---|
Description | Estimated proportion of missed doses by pill count (assuming pills taken in unreturned bottles) |
Time Frame | At 24 weeks |
Outcome Measure Data
Analysis Population Description |
---|
Those who bottles returned at the week 24 visit. |
Arm/Group Title | TDF/FTC | Placebo |
---|---|---|
Arm/Group Description | Daily oral emtricitabine/tenofovir disoproxil fumarate Emtricitabine/tenofovir disoproxil fumarate: Fixed-dose coformulation of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate | Daily oral placebo Placebo: Placebo for emtricitabine/tenofovir disoproxil fumarate |
Measure Participants | 983 | 999 |
Mean (95% Confidence Interval) [proportion of pills not returned] |
0.92
|
0.93
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | TDF/FTC, Placebo |
---|---|---|
Comments | Null hypothesis is equal proportion of pills returned | |
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.53 |
Comments | ||
Method | Mixed Models Analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Net) |
Estimated Value | -0.005 | |
Confidence Interval |
(2-Sided) 95% -0.02 to 0.01 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Percentage of Missed Doses by Estimate During CASI Interview |
---|---|
Description | Percentage of missed doses by estimate during computer assisted structured interview |
Time Frame | Week 24 |
Outcome Measure Data
Analysis Population Description |
---|
All participants who answered the adherence question with an estimated adherence on the week 24 computer assisted structured interview |
Arm/Group Title | TDF/FTC | Placebo |
---|---|---|
Arm/Group Description | Daily oral emtricitabine/tenofovir disoproxil fumarate | Daily oral placebo |
Measure Participants | 884 | 902 |
Mean (Standard Error) [percentage of doses taken] |
91.0
(0.5)
|
91.2
(0.50)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | TDF/FTC, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.70 |
Comments | ||
Method | t-test, 2 sided | |
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Net) |
Estimated Value | 0.25 | |
Confidence Interval |
(2-Sided) 95% -1.1 to 1.6 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | ||
Other Statistical Analysis | Detailed methods and results are available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4110718/ |
Title | Number of Condomless Sexual Partners With HIV Positive or Unknown Status |
---|---|
Description | Participants self-report of the number of sexual partners with HIV positive or unknown status in the previous 12 weeks with whom they had condomless anal sex |
Time Frame | At 24 weeks |
Outcome Measure Data
Analysis Population Description |
---|
Participants interviewed about sexual practices at week 24 |
Arm/Group Title | TDF/FTC | Placebo |
---|---|---|
Arm/Group Description | Daily oral emtricitabine/tenofovir disoproxil fumarate | Daily oral placebo |
Measure Participants | 1091 | 1114 |
Median (Inter-Quartile Range) [count] |
0
|
0
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | TDF/FTC, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.99 |
Comments | Not adjusted for multiple comparisons and the a priori threshold for statistical significance was p < 0.05 | |
Method | Wilcoxon (Mann-Whitney) | |
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
Estimated Value | 0 | |
Confidence Interval |
(2-Sided) % to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Total Number of Sexual Partners |
---|---|
Description | Self-reported total number of sexual partners in the previous 12 weeks. |
Time Frame | 24 weeks |
Outcome Measure Data
Analysis Population Description |
---|
Participants interviewed about sexual practices at week 24 |
Arm/Group Title | TDF/FTC | Placebo |
---|---|---|
Arm/Group Description | Daily oral emtricitabine/tenofovir disoproxil fumarate | Daily oral placebo |
Measure Participants | 1091 | 1114 |
Median (Inter-Quartile Range) [Count] |
3
|
3
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | TDF/FTC, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.76 |
Comments | Not adjusted for multiple comparisons, a priori threshold for statistical significance, p < 0.05 | |
Method | Wilcoxon (Mann-Whitney) | |
Comments | ||
Method of Estimation | Estimation Parameter | Median Difference (Final Values) |
Estimated Value | 0 | |
Confidence Interval |
(2-Sided) 95% -.42 to .42 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | ||
Other Statistical Analysis | Full details available in the methods section of https://www.ncbi.nlm.nih.gov/pubmed/24367497 |
Title | Condomless Receptive Anal Intercourse in the Previous 12 Weeks With Any Partners Regardless of Status. |
---|---|
Description | Self-reported condomless receptive anal intercourse in the previous 12 weeks with any partners regardless of status. |
Time Frame | At 24 weeks |
Outcome Measure Data
Analysis Population Description |
---|
Participants interviewed about sexual practices at week 24 |
Arm/Group Title | TDF/FTC | Placebo |
---|---|---|
Arm/Group Description | Daily oral emtricitabine/tenofovir disoproxil fumarate Emtricitabine/tenofovir disoproxil fumarate: Fixed-dose coformulation of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate | Daily oral placebo Placebo: Placebo for emtricitabine/tenofovir disoproxil fumarate |
Measure Participants | 1091 | 1114 |
Count of Participants [Participants] |
332
26.5%
|
348
27.9%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | TDF/FTC, Placebo |
---|---|---|
Comments | Null is no difference between arms | |
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.68 |
Comments | ||
Method | Chi-squared | |
Comments | ||
Method of Estimation | Estimation Parameter | Risk Difference (RD) |
Estimated Value | -0.008 | |
Confidence Interval |
(2-Sided) 95% -0.047 to 0.030 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Incidence of Confirmed Syphilis During Follow-Up |
---|---|
Description | Number of participants who have at least 1 confirmed syphilis infection during the study |
Time Frame | All Follow-Up median of 1.2 years of follow-up |
Outcome Measure Data
Analysis Population Description |
---|
Participants without active syphilis at baseline with a follow-up syphilis test. |
Arm/Group Title | TDF/FTC | Placebo |
---|---|---|
Arm/Group Description | Daily oral emtricitabine/tenofovir disoproxil fumarate Emtricitabine/tenofovir disoproxil fumarate: Fixed-dose coformulation of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate | Daily oral placebo Placebo: Placebo for emtricitabine/tenofovir disoproxil fumarate |
Measure Participants | 1155 | 1171 |
Count of Participants [Participants] |
147
11.8%
|
132
10.6%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | TDF/FTC, Placebo |
---|---|---|
Comments | Null hypothesis of no difference between the arms | |
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.30 |
Comments | ||
Method | Log Rank | |
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 1.13 | |
Confidence Interval |
(2-Sided) 95% 0.89 to 1.43 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Incidence of HSV-2 During the Follow-up Period |
---|---|
Description | Incidence of HSV-2 during the follow-up period among those HIV-2 negative at baseline |
Time Frame | Total study follow-up, a median of 1.2 years |
Outcome Measure Data
Analysis Population Description |
---|
All HSV-2 negative participants with a follow-up HSV-2 test. |
Arm/Group Title | TDF/FTC | Placebo |
---|---|---|
Arm/Group Description | Daily oral emtricitabine/tenofovir disoproxil fumarate | Daily oral placebo |
Measure Participants | 671 | 676 |
Count of Participants [Participants] |
65
5.2%
|
60
4.8%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | TDF/FTC, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.41 |
Comments | ||
Method | Log Rank | |
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 1.2 | |
Confidence Interval |
(2-Sided) 95% 0.8 to 1.7 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments | ||
Other Statistical Analysis | Details in the manuscript https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3956614/ |
Title | Diagnosis of Gonorrhea During the Follow-up Period |
---|---|
Description | Diagnosis of gonorrhea during the follow-up period by PCR |
Time Frame | All of follow-up period, median of 1.2 years |
Outcome Measure Data
Analysis Population Description |
---|
All participants with at least one follow-up test for gonorrhea |
Arm/Group Title | TDF/FTC | Placebo |
---|---|---|
Arm/Group Description | Daily oral emtricitabine/tenofovir disoproxil fumarate | Daily oral placebo |
Measure Participants | 1226 | 1229 |
Count of Participants [Participants] |
18
1.4%
|
30
2.4%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | TDF/FTC, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.09 |
Comments | ||
Method | Log Rank | |
Comments | ||
Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
Estimated Value | 0.61 | |
Confidence Interval |
(2-Sided) 95% 0.34 to 1.09 |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Adverse Events
Time Frame | Monthly follow-up with quarterly lab assessments though a median of 1.2 years of follow-up | |||
---|---|---|---|---|
Adverse Event Reporting Description | Adverse events graded by the NIH Division of AIDS grading tables, version 1.0 | |||
Arm/Group Title | TDF/FTC | Placebo | ||
Arm/Group Description | Daily oral emtricitabine/tenofovir disoproxil fumarate Emtricitabine/tenofovir disoproxil fumarate: Fixed-dose coformulation of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate | Daily oral placebo Placebo: Placebo for emtricitabine/tenofovir disoproxil fumarate | ||
All Cause Mortality |
||||
TDF/FTC | Placebo | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
TDF/FTC | Placebo | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 92/1226 (7.5%) | 94/1230 (7.6%) | ||
Blood and lymphatic system disorders | ||||
CREATININE INCREASE | 9/1226 (0.7%) | 9 | 7/1230 (0.6%) | 7 |
ALT INCREASE | 1/1226 (0.1%) | 1 | 4/1230 (0.3%) | 4 |
AST | 4/1226 (0.3%) | 4 | 5/1230 (0.4%) | 5 |
General disorders | ||||
OTHER EVENTS | 28/1226 (2.3%) | 28 | 29/1230 (2.4%) | 29 |
Hepatobiliary disorders | ||||
APPENDICITIS | 3/1226 (0.2%) | 3 | 3/1230 (0.2%) | 3 |
Musculoskeletal and connective tissue disorders | ||||
Bone Fracture | 8/1226 (0.7%) | 8 | 9/1230 (0.7%) | 9 |
Psychiatric disorders | ||||
SUICIDE ATTEMPT | 17/1226 (1.4%) | 17 | 14/1230 (1.1%) | 14 |
SUICIDAL IDEATION | 5/1226 (0.4%) | 5 | 6/1230 (0.5%) | 6 |
DEPRESSION | 7/1226 (0.6%) | 7 | 11/1230 (0.9%) | 11 |
SUICIDAL DEPRESSION | 5/1226 (0.4%) | 5 | 6/1230 (0.5%) | 6 |
MAJOR DEPRESSION | 5/1226 (0.4%) | 5 | 0/1230 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
TDF/FTC | Placebo | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 906/1226 (73.9%) | 937/1230 (76.2%) | ||
Gastrointestinal disorders | ||||
PARASITIC INFECTION INTESTINAL | 231/1226 (18.8%) | 231 | 216/1230 (17.6%) | 216 |
DIARRHOEA | 109/1226 (8.9%) | 109 | 123/1230 (10%) | 123 |
Infections and infestations | ||||
SYPHILIS | 82/1226 (6.7%) | 82 | 71/1230 (5.8%) | 71 |
UPPER RESPIRATORY TRACT INFECTION | 73/1226 (6%) | 73 | 76/1230 (6.2%) | 76 |
SECONDARY SYPHILIS | 81/1226 (6.6%) | 81 | 64/1230 (5.2%) | 64 |
BLOOD AMYLASE INCREASED | 62/1226 (5.1%) | 62 | 57/1230 (4.6%) | 57 |
Investigations | ||||
ALANINE AMINOTRANSFERASE INCREASED | 151/1226 (12.3%) | 151 | 155/1230 (12.6%) | 155 |
BILIRUBIN INCREASE | 127/1226 (10.4%) | 127 | 132/1230 (10.7%) | 132 |
BLOOD GLUCOSE INCREASED | 109/1226 (8.9%) | 109 | 123/1230 (10%) | 123 |
BLOOD PHOSPHORUS DECREASED | 122/1226 (10%) | 122 | 100/1230 (8.1%) | 100 |
ASPARTATE AMINOTRANSFERASE INCREASED | 76/1226 (6.2%) | 76 | 93/1230 (7.6%) | 93 |
Musculoskeletal and connective tissue disorders | ||||
BACK PAIN | 84/1226 (6.9%) | 84 | 87/1230 (7.1%) | 87 |
Nervous system disorders | ||||
HEADACHE | 102/1226 (8.3%) | 102 | 107/1230 (8.7%) | 107 |
DEPRESSION | 81/1226 (6.6%) | 81 | 84/1230 (6.8%) | 84 |
Renal and urinary disorders | ||||
URETHRITIS | 84/1226 (6.9%) | 84 | 102/1230 (8.3%) | 102 |
Respiratory, thoracic and mediastinal disorders | ||||
PHARYNGITIS | 248/1226 (20.2%) | 248 | 282/1230 (22.9%) | 282 |
NASOPHARYNGITIS | 98/1226 (8%) | 98 | 92/1230 (7.5%) | 92 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT 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 | David Glidden |
---|---|
Organization | University of California, San Francisco |
Phone | 415-514-8009 |
david.glidden@ucsf.edu |
- CO-US-104-0288
- 10445
- 1U01AI064002
- iPrEx
- NCT00350324