A Study With TMC125 in Human Immunodeficiency Virus (HIV) Type 1 Infected Patients, Who Were Treated With TMC125 Arm in a Sponsor-Selected TMC125 Study

• Sponsor: Tibotec Pharmaceuticals, Ireland (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00128830
• Collaborator: (none)
• Enrollment: 211
• Arm: 1
• Duration (Months): 38

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the long-term safety and tolerability of etravirine, administered as part of an individually optimized antiretroviral therapy (ART), in human immunodeficiency virus Type 1 (HIV-1) infected participants.

Condition or Disease	Intervention/Treatment	Phase
Human Immunodeficiency Virus Type 1	Drug: Etravirine (ETR); Drug: Nucleotide reverse transcriptase inhibitors (NRTIs); Drug: Protease inhibitors (PIs); Drug: Enfuvirtide (ENF)	Phase 2

Detailed Description

This is a Phase II, open-label (all people know the identity of the intervention), roll-over study (participants may go ahead and participate in another clinical study). Participants who were randomized (study medication is assigned by chance) to a etravirine (ETR) treatment arm in Phase II TMC125 feeder studies (TMC125-C203, TMC125-C209, TMC125-C223 and TMC125-C211), were treated for at least 48 weeks with etravirine, and who will derive continued benefit from etravirine therapy, as judged by the investigator, will be enrolled in this study. The final visit of the sponsor-selected Phase II ETR study will be the first (baseline) visit of this study. Approximately 300 participants will be enrolled in this study who will receive 800 mg twice daily of etravirine (formulation TF035) until the formulation 200 mg twice daily (formulation F060) is available. Once this formulation becomes available all the participants will be switched to receive F060 which will be given in combination with an investigator-selected, optimized underlying therapy (nucleotide reverse transcriptase [NRTIs] and/or allowed protease inhibitors and/or enfuvirtide). Participants will continue to receive ETR until they are no longer benefitted or this medication becomes commercially available. Safety evaluations will include assessment of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination.

Study Design

• Study Type: Interventional
• Actual Enrollment: 211 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-Label Trial With TMC125 in HIV-1 Infected Subjects, Who Were Randomized to a TMC125 Treatment Arm in a Sponsor-Selected TMC125 Trial and Were Treated for at Least 48 Weeks
• Study Start Date: Jun 1, 2005
• Actual Primary Completion Date: Aug 1, 2008
• Actual Study Completion Date: Aug 1, 2008

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Etravirine + 2 antiretrovirals

Drug: Etravirine (ETR); Participants will receive 800 mg of ETR (2 x 4 tablets of formulation TF035) twice daily and after the formulation switch they will receive 200 mg of ETR (2 x 2 tablets of formulation F060) twice daily until the participants benefitted from etravirine or it became comercially available.; Other Names: TMC125 ; Drug: Nucleotide reverse transcriptase inhibitors (NRTIs); Participants will receive 2 additonal approved antiretrovirals (ARVs) along with ETR. ARVs may be NRTIs and/or allowed protease inhibitors (PIs) and/or enfuvirtide (ENF).; Drug: Protease inhibitors (PIs); Participants will receive 2 additonal approved antiretrovirals (ARVs) along with ETR. ARVs may be NRTIs and/or allowed protease inhibitors (PIs) and/or enfuvirtide (ENF).; Drug: Enfuvirtide (ENF); Participants will receive 2 additonal approved antiretrovirals (ARVs) along with ETR. ARVs may be NRTIs and/or allowed protease inhibitors (PIs) and/or enfuvirtide (ENF).

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Adverse Events [Up to 3 years]

   Number of participants who reported at least 1 of the adverse events.

Secondary Outcome Measures

1. Number of Participants Who Achieved Virologic Response (ie, Viral Load Less Than 50 Copies/mL) at Week 48 [Week 48]

   Number of participants who had viral load more than or equal to 50 copies/mL and less than 50 copies/mL at TMC125-C229 baseline and who achieved virologic response (ie, viral load less than 50 copies/mL) at Week 48. The last visit of the TMC125 feeder study (TMC125-C203 [NCT00412646], TMC125-C223 [NCT00081978], TMC125 C211 [NCT00111280] or TMC125-C209 feeder studies) was considered to be the TMC125-C229 baseline.

2. Number of Participants Who Achieved Virologic Response (ie, Viral Load Less Than 50 Copies/mL) at Week 96 [Week 96]

   Number of participants who had viral load more than or equal to 50 copies/mL and less than 50 copies/mL at TMC125-C229 baseline and who achieved virologic response (ie, viral load less than 50 copies/mL) at Week 96. The last visit of the TMC125 feeder study (TMC125-C203 [NCT00412646], TMC125-C223 [NCT00081978], TMC125 C211 [NCT00111280] or TMC125-C209 feeder studies) was considered to be the TMC125-C229 baseline.

3. Number of Participants Who Achieved Virologic Response (ie, Viral Load Less Than 50 Copies/mL; Less Than 400 Copies/mL; and Greater Than or Equal to 1 Log 10 Decrease From Baseline) at Week 96 [Week 96]

   Baseline considered for this outcome is the baseline in the respective TMC125-C229 feeder study (TMC125-C203 [NCT00412646], TMC125-C223 [NCT00081978], TMC125 C211 [NCT00111280] or TMC125-C209 feeder studies).

4. Number of Participants Who Achieved Virologic Response (ie, Viral Load Less Than 50 Copies/mL; Viral Load Less Than 400 Copies/mL; and Greater Than or Equal to 1 log10 Decrease From Baseline) at Week 192 [Week 192]

   Baseline considered for this outcome is the baseline in the respective TMC125-C229 feeder study (TMC125-C203 [NCT00412646], TMC125-C223 [NCT00081978], TMC125 C211 [NCT00111280] or TMC125-C209 feeder studies).

5. Median Change From TMC125-C229 Basline in Cluster of Differentiation 4 (CD4+) Cell Count at Week 48 [Week 48]

   The last visit of the TMC125 feeder study (TMC125-C203 [NCT00412646], TMC125-C223 [NCT00081978], TMC125 C211 [NCT00111280] or TMC125-C209 feeder studies) was considered to be the TMC125-C229 baseline.

6. Median Change From TMC125-C229 Baseline in Cluster of Differentiation 4 (CD4+) Cell Count at Week 96 [Week 96]

   The last visit of the TMC125 feeder study (TMC125-C203 [NCT00412646], TMC125-C223 [NCT00081978], TMC125 C211 [NCT00111280] or TMC125-C209 feeder studies) was considered to be the TMC125-C229 baseline.

7. Median Change in Cluster of Differentiation 4 (CD4+) Cell Count From Baseline in TMC125-C229 Feeder Study at Week 96 [Week 96]

   Baseline considered for this outcome is the baseline in the respective TMC125-C229 feeder study (TMC125-C203 [NCT00412646], TMC125-C223 [NCT00081978], TMC125 C211 [NCT00111280] or TMC125-C209 feeder studies).

8. Median Change in Cluster of Differentiation 4 (CD4+) Cell Count From Baseline in TMC125-C229 Feeder Study at Week 192 [Week 192]

   Baseline considered for this outcome is the baseline in the respective TMC125-C229 feeder study (TMC125-C203 [NCT00412646], TMC125-C223 [NCT00081978], TMC125 C211 [NCT00111280] or TMC125-C209 feeder studies).

9. Number of Participants With Emerging Mutation (Reverse Transcriptase Mutation) [Baseline and Endpoint (ie, the last available time point during the treatment period)]

   Emerging mutations are the mutation which are not present at baseline (last visit of the TMC125 feeder study [TMC125-C203 (NCT00412646), TMC125-C223 (NCT00081978), TMC125 C211 (NCT00111280) or TMC125-C209 feeder studies]) and are present at endpoint (last available timepoint during treatment period for each individual participant).

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Participants who were previously randomized to an etravirine (ETR) treatment arm and have completed at least 48 weeks of treatment with ETR

• Participants who will be able to comply with the protocol requirements

• Participants general medical condition should not interfere with the assessments and the completion of the study

Exclusion Criteria:

• Use of disallowed concomitant therapy unless a prior exemption had been granted

• Participant with any treatment-emergent condition or exacerbation of underlying condition during original Phase II study

• Agrees to protocol-defined use of effective contraception

• Participant with a grade 3 elevation of amylase and/or lipase except for isolated grade 3 increases of amylase with lipase in normal range and no history of pancreatitis

• Participant with any grade 4 toxicity according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) grading table; with the exception of grade 4 elevations of triglycerides or glucose asymptomatic or under non-fasting conditions; grade 4 elevation of glucose in participants with pre-existing diabetes

• Participants with clinical or laboratory evidence of significantly decreased hepatic function or decompensation, irrespective of liver enzyme levels (International Normalized Ratio [INR] more than 1.5 or albumin less than 30g/l or bilirubin more than 2.5 x upper limit of normal)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Tibotec Pharmaceuticals, Ireland

Investigators

• Study Director: Tibotec Pharmaceuticals, Ireland Clinical Trial, Tibotec Pharmaceuticals, Ireland

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• TMC125-C229: TMC125 in HIV-1 Infected Subjects, Who Were Randomized to a TMC125 Treatment Arm in a Sponsor Selected TMC125 Trial and Were Treated for at Least 48 Weeks

Publications

None provided.

• Responsible Party: Tibotec Pharmaceuticals, Ireland
• ClinicalTrials.gov Identifier: NCT00128830
• Other Study ID Numbers: CR002731; TMC125-C229; NCT00980772
• First Posted: Aug 10, 2005
• Last Update Posted: Jun 20, 2013
• Last Verified: Jun 1, 2013

• Keywords provided by Tibotec Pharmaceuticals, Ireland: Human Immunodeficiency Virus Type 1; HIV-1 infection; TMC125; Etravirine; Enfuvirtide; Antiretroviral therapy
• Additional relevant MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes; Reverse Transcriptase Inhibitors; Etravirine; Enfuvirtide; HIV Protease Inhibitors; Protease Inhibitors

Study Results

Participant Flow

Recruitment Details	In this study, 211 participants were enrolled in 12 different countries. The majority of participants (49%) were enrolled in the United States.
Pre-assignment Detail	In total, 211 participants (93 who rolled over from the etravirine arm of study TMC125-C203 (NCT00412646), 85 who rolled over from the etravirine arm of study TMC125-C223 (NCT00081978), 29 who rolled over from study TMC125-C211 (NCT00111280) and 4 who rolled over from study TMC125-C209) received treatment with etravirine.

Arm/Group Title	Etravirine
Arm/Group Description	800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060)
Period Title: Overall Study
STARTED	211
COMPLETED	139
NOT COMPLETED	72

Baseline Characteristics

Arm/Group Title	Etravirine
Arm/Group Description	800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060)
Overall Participants	211
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	46.0 (7.56)
Sex: Female, Male (Count of Participants)
Female	21 10%
Male	190 90%
Race/Ethnicity, Customized (Number) [Number]
Asian	1 0.5%
Black or African American	24 11.4%
White	164 77.7%
Hispanic	16 7.6%
Other	6 2.8%

Outcome Measures

1. Secondary Outcome

Title	Number of Participants Who Achieved Virologic Response (ie, Viral Load Less Than 50 Copies/mL) at Week 48
Description	Number of participants who had viral load more than or equal to 50 copies/mL and less than 50 copies/mL at TMC125-C229 baseline and who achieved virologic response (ie, viral load less than 50 copies/mL) at Week 48. The last visit of the TMC125 feeder study (TMC125-C203 [NCT00412646], TMC125-C223 [NCT00081978], TMC125 C211 [NCT00111280] or TMC125-C209 feeder studies) was considered to be the TMC125-C229 baseline.
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

Intent-to-treat participants who received at least one dose of study medication with evaluable data at Week 48

Arm/Group Title	Viral Load More Than or Equal to 50 Copies/mL	Viral Load Less Than 50 Copies/mL
Arm/Group Description	Viral load more than or equal to 50 copies/mL at TMC125-C229 Baseline	Viral load less than 50 copies/mL at TMC125-C229 Baseline
Measure Participants	80	93
Number [Participants]	22 10.4%	80 NaN

2. Secondary Outcome

Title	Number of Participants Who Achieved Virologic Response (ie, Viral Load Less Than 50 Copies/mL) at Week 96
Description	Number of participants who had viral load more than or equal to 50 copies/mL and less than 50 copies/mL at TMC125-C229 baseline and who achieved virologic response (ie, viral load less than 50 copies/mL) at Week 96. The last visit of the TMC125 feeder study (TMC125-C203 [NCT00412646], TMC125-C223 [NCT00081978], TMC125 C211 [NCT00111280] or TMC125-C209 feeder studies) was considered to be the TMC125-C229 baseline.
Time Frame	Week 96

Outcome Measure Data

Analysis Population Description

Intent-to-treat participants who received at least one dose of study medication with evaluable data at Week 96

Arm/Group Title	Viral Load More Than or Equal to 50 Copies/mL	Viral Load Less Than 50 Copies/mL
Arm/Group Description	Viral load more than or equal to 50 copies/mL at TMC125-C229 Baseline	Viral load less than 50 copies/mL at TMC125-C229 Baseline
Measure Participants	62	83
Number [Participants]	28 13.3%	72 NaN

3. Secondary Outcome

Title	Number of Participants Who Achieved Virologic Response (ie, Viral Load Less Than 50 Copies/mL; Less Than 400 Copies/mL; and Greater Than or Equal to 1 Log 10 Decrease From Baseline) at Week 96
Description	Baseline considered for this outcome is the baseline in the respective TMC125-C229 feeder study (TMC125-C203 [NCT00412646], TMC125-C223 [NCT00081978], TMC125 C211 [NCT00111280] or TMC125-C209 feeder studies).
Time Frame	Week 96

Outcome Measure Data

Analysis Population Description

Intent-to-treat participants who received at least one dose of study medication with evaluable data at Week 96

Arm/Group Title	Etravirine
Arm/Group Description	800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060)
Measure Participants	181
Viral load (VL) less than 50 copies/mL	105 49.8%
Viral load less than 400 copies/mL	124 58.8%
Viral load more than or equal to 1log10	132 62.6%

4. Secondary Outcome

Title	Number of Participants Who Achieved Virologic Response (ie, Viral Load Less Than 50 Copies/mL; Viral Load Less Than 400 Copies/mL; and Greater Than or Equal to 1 log10 Decrease From Baseline) at Week 192
Description	Baseline considered for this outcome is the baseline in the respective TMC125-C229 feeder study (TMC125-C203 [NCT00412646], TMC125-C223 [NCT00081978], TMC125 C211 [NCT00111280] or TMC125-C209 feeder studies).
Time Frame	Week 192

Outcome Measure Data

Analysis Population Description

Intent-to-treat participants who received at least one dose of study medication with evaluable data at Week 192

Arm/Group Title	Etravirine
Arm/Group Description	800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060)
Measure Participants	98
Viral load (VL) less than 50 copies/mL	69 32.7%
VL less than 400 copies/mL	81 38.4%
VL greater than or equal to 1log10	83 39.3%

5. Secondary Outcome

Title	Median Change From TMC125-C229 Basline in Cluster of Differentiation 4 (CD4+) Cell Count at Week 48
Description	The last visit of the TMC125 feeder study (TMC125-C203 [NCT00412646], TMC125-C223 [NCT00081978], TMC125 C211 [NCT00111280] or TMC125-C209 feeder studies) was considered to be the TMC125-C229 baseline.
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

Intent-to-treat participants who received at least one dose of study medication with evaluable data at Week 48

Arm/Group Title	Etravirine
Arm/Group Description	800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060)
Measure Participants	172
Median (Full Range) [x 100000 cells/L]	21.50

6. Secondary Outcome

Title	Median Change From TMC125-C229 Baseline in Cluster of Differentiation 4 (CD4+) Cell Count at Week 96
Description	The last visit of the TMC125 feeder study (TMC125-C203 [NCT00412646], TMC125-C223 [NCT00081978], TMC125 C211 [NCT00111280] or TMC125-C209 feeder studies) was considered to be the TMC125-C229 baseline.
Time Frame	Week 96

Outcome Measure Data

Analysis Population Description

Intent-to-treat participants who received at least one dose of study medication with evaluable data at Week 96

Arm/Group Title	Etravirine
Arm/Group Description	800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060)
Measure Participants	142
Median (Full Range) [x 1000000 cells/L]	18.50

7. Secondary Outcome

Title	Median Change in Cluster of Differentiation 4 (CD4+) Cell Count From Baseline in TMC125-C229 Feeder Study at Week 96
Description	Baseline considered for this outcome is the baseline in the respective TMC125-C229 feeder study (TMC125-C203 [NCT00412646], TMC125-C223 [NCT00081978], TMC125 C211 [NCT00111280] or TMC125-C209 feeder studies).
Time Frame	Week 96

Outcome Measure Data

Analysis Population Description

Intent-to-treat participants who received at least one dose of study medication with evaluable data at Week 96

Arm/Group Title	Etravirine
Arm/Group Description	800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060)
Measure Participants	181
Median (Full Range) [x 1000000 cells/mL]	120.00

8. Secondary Outcome

Title	Median Change in Cluster of Differentiation 4 (CD4+) Cell Count From Baseline in TMC125-C229 Feeder Study at Week 192
Description	Baseline considered for this outcome is the baseline in the respective TMC125-C229 feeder study (TMC125-C203 [NCT00412646], TMC125-C223 [NCT00081978], TMC125 C211 [NCT00111280] or TMC125-C209 feeder studies).
Time Frame	Week 192

Outcome Measure Data

Analysis Population Description

Intent-to-treat participants who received at least one dose of study medication with evaluable data at Week 192

Arm/Group Title	Etravirine
Arm/Group Description	800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060)
Measure Participants	96
Median (Full Range) [x 1000000 cells/mL]	149.50

9. Secondary Outcome

Title	Number of Participants With Emerging Mutation (Reverse Transcriptase Mutation)
Description	Emerging mutations are the mutation which are not present at baseline (last visit of the TMC125 feeder study [TMC125-C203 (NCT00412646), TMC125-C223 (NCT00081978), TMC125 C211 (NCT00111280) or TMC125-C209 feeder studies]) and are present at endpoint (last available timepoint during treatment period for each individual participant).
Time Frame	Baseline and Endpoint (ie, the last available time point during the treatment period)

Outcome Measure Data

Analysis Population Description

Intent-to-treat population: Participants who received at least 1 dose of study medication were included

Arm/Group Title	Etravirine
Arm/Group Description	800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060)
Measure Participants	211
L100I	8 3.8%
Y181C	7 3.3%
A98G	6 2.8%
V179I	6 2.8%
K103N	5 2.4%
H221Y	5 2.4%

10. Primary Outcome

Title	Number of Participants With Adverse Events
Description	Number of participants who reported at least 1 of the adverse events.
Time Frame	Up to 3 years

Outcome Measure Data

Analysis Population Description

Intent-to-treat population: Participants who received at least 1 dose of study medication were included

Arm/Group Title	Etravirine
Arm/Group Description	800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060)
Measure Participants	211
Number [Participants]	195 92.4%

Adverse Events

Time Frame	Up to 3 years
Arm/Group Title	Etravirine
Arm/Group Description	800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060)
All Cause Mortality
	Etravirine
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Etravirine
	Affected / at Risk (%)	# Events
Total	46/211 (21.8%)
Blood and lymphatic system disorders
Febrile neutropenia	1/211 (0.5%)
Cardiac disorders
Acute coronary syndrome	1/211 (0.5%)
Acute myocardial infarction	1/211 (0.5%)
Angina pectoris	1/211 (0.5%)
Angina unstable	1/211 (0.5%)
Arrhythmia	1/211 (0.5%)
Atrial flutter	1/211 (0.5%)
Cardiogenic shock	1/211 (0.5%)
Coronary artery disease	1/211 (0.5%)
Coronary artery occlusion	1/211 (0.5%)
Myocardial infarction	2/211 (0.9%)
Myocardial ischaemia	1/211 (0.5%)
Congenital, familial and genetic disorders
Fanconi syndrome	1/211 (0.5%)
Endocrine disorders
Adrenal insufficiency	2/211 (0.9%)
Gastrointestinal disorders
Abdominal distension	1/211 (0.5%)
Diarrhoea haemorrhagic	1/211 (0.5%)
Gastritis	2/211 (0.9%)
Pancreatitis	2/211 (0.9%)
Upper gastrointestinal haemorrhage	1/211 (0.5%)
General disorders
Chest discomfort	1/211 (0.5%)
Chills	1/211 (0.5%)
Pyrexia	1/211 (0.5%)
Hepatobiliary disorders
Cholecystitis	1/211 (0.5%)
Cholecystitis acute	1/211 (0.5%)
Infections and infestations
Acute sinusitis	1/211 (0.5%)
Arthritis bacterial	1/211 (0.5%)
Arthritis infective	1/211 (0.5%)
Bacteraemia	1/211 (0.5%)
Bronchitis	1/211 (0.5%)
Cellulitis	3/211 (1.4%)
Gastrointestinal infection	1/211 (0.5%)
Groin abscess	1/211 (0.5%)
Herpes simplex	1/211 (0.5%)
Histoplasmosis disseminated	1/211 (0.5%)
Meningitis aseptic	1/211 (0.5%)
Pneumocystis jiroveCI pneumonia	2/211 (0.9%)
Pneumonia	5/211 (2.4%)
Pneumonia viral	1/211 (0.5%)
Respiratory tract infection	1/211 (0.5%)
Secondary syphilis	1/211 (0.5%)
Sepsis	1/211 (0.5%)
Staphylococcal abscess	1/211 (0.5%)
Subcutaneous abscess	1/211 (0.5%)
Urinary tract infection	1/211 (0.5%)
Injury, poisoning and procedural complications
Femur fracture	1/211 (0.5%)
Hip fracture	1/211 (0.5%)
Injury	1/211 (0.5%)
Radius fracture	1/211 (0.5%)
Tibia fracture	1/211 (0.5%)
Traumatic brain injury	1/211 (0.5%)
Investigations
Biopsy kidney	1/211 (0.5%)
Biopsy liver	1/211 (0.5%)
Metabolism and nutrition disorders
Dehydration	2/211 (0.9%)
Diabetes mellitus non-insulin-dependent	1/211 (0.5%)
Metabolic acidosis	1/211 (0.5%)
Musculoskeletal and connective tissue disorders
Muscle spasms	1/211 (0.5%)
Musculoskeletal chest pain	1/211 (0.5%)
Osteoarthritis	1/211 (0.5%)
Osteonecrosis	1/211 (0.5%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal cancer recurrent	1/211 (0.5%)
Breast cancer	1/211 (0.5%)
Gum neoplasm malignant stage unspecified	1/211 (0.5%)
Hepatic neoplasm	1/211 (0.5%)
Hepatic neoplasm malignant	1/211 (0.5%)
Hodgkin's disease	1/211 (0.5%)
Kaposi's sarcoma	1/211 (0.5%)
Metastases to liver	1/211 (0.5%)
Metastases to peritoneum	1/211 (0.5%)
Pancreatic neoplasm	1/211 (0.5%)
Prostate cancer	1/211 (0.5%)
Nervous system disorders
Chronic inflammatory demyelinating polyradiculoneuropathy	1/211 (0.5%)
Headache	1/211 (0.5%)
Renal and urinary disorders
Renal artery occlusion	1/211 (0.5%)
Renal failure acute	2/211 (0.9%)
Renal impairment	1/211 (0.5%)
Reproductive system and breast disorders
Prostatitis	1/211 (0.5%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea	1/211 (0.5%)
Pulmonary artery thrombosis	1/211 (0.5%)
Skin and subcutaneous tissue disorders
Decubitus ulcer	1/211 (0.5%)
Surgical and medical procedures
Abdominoplasty	1/211 (0.5%)
Hospitalisation	1/211 (0.5%)
Wound treatment	1/211 (0.5%)
Vascular disorders
Hypertension	1/211 (0.5%)
Other (Not Including Serious) Adverse Events
	Etravirine
	Affected / at Risk (%)	# Events
Total	147/211 (69.7%)
Blood and lymphatic system disorders
Lymphadenopathy	22/211 (10.4%)
Gastrointestinal disorders
Abdominal pain	16/211 (7.6%)
Diarrhoea	37/211 (17.5%)
Nausea	18/211 (8.5%)
Vomiting	11/211 (5.2%)
General disorders
Fatigue	23/211 (10.9%)
Injection site reaction	15/211 (7.1%)
Pyrexia	16/211 (7.6%)
Infections and infestations
Bronchitis	15/211 (7.1%)
Nasopharyngitis	23/211 (10.9%)
Sinusitis	24/211 (11.4%)
Upper respiratory tract infection	36/211 (17.1%)
Musculoskeletal and connective tissue disorders
Arthralgia	23/211 (10.9%)
Back pain	19/211 (9%)
Myalgia	12/211 (5.7%)
Pain in extremity	13/211 (6.2%)
Nervous system disorders
Headache	20/211 (9.5%)
Psychiatric disorders
Depression	11/211 (5.2%)
Respiratory, thoracic and mediastinal disorders
Cough	20/211 (9.5%)
Skin and subcutaneous tissue disorders
Rash	16/211 (7.6%)
Vascular disorders
Hypertension	11/211 (5.2%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.