Trial Outcomes & Findings for Botswana TDF/FTC Oral HIV Prophylaxis Trial (NCT NCT00448669)

NCT ID: NCT00448669

Last Updated: 2020-02-05

Results Overview

Study visits were scheduled every 30 days until completion of the study, and participants were instructed to return to the clinic for evaluation in the event of an illness. Participants reported any adverse effects at monthly visits and interim visits.

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 1219 participants
• Primary outcome timeframe: Monthly, for up to 3 years
• Results posted on: 2020-02-05

Participant Flow

Participant milestones

Measure	TDF-FTC, Condoms, Risk Counseling Participants randomized to the active arm received daily oral TDF-FTC along with male and female condoms, personalized risk reduction counseling, adherence counseling, and routine monitoring for HIV infection, laboratory abnormalities, and adverse events. Tenofovir Disoproxil Fumarate 300 mg + Emtricitabine 200 mg: Daily oral single dose pill containing 300 mg TDF and 200 mg FTC.	Placebo, Condoms, Risk Counseling Participants randomized to the placebo arm received a daily oral placebo tablet along with male and female condoms, personalized risk reduction counseling, adherence counseling, and routine monitoring for HIV infection, laboratory abnormalities, and adverse events. TDF-FTC placebo: Placebo comparator for TDF-FTC
Overall Study STARTED	611	608
Overall Study COMPLETED	393	410
Overall Study NOT COMPLETED	218	198

Reasons for withdrawal

Measure	TDF-FTC, Condoms, Risk Counseling Participants randomized to the active arm received daily oral TDF-FTC along with male and female condoms, personalized risk reduction counseling, adherence counseling, and routine monitoring for HIV infection, laboratory abnormalities, and adverse events. Tenofovir Disoproxil Fumarate 300 mg + Emtricitabine 200 mg: Daily oral single dose pill containing 300 mg TDF and 200 mg FTC.	Placebo, Condoms, Risk Counseling Participants randomized to the placebo arm received a daily oral placebo tablet along with male and female condoms, personalized risk reduction counseling, adherence counseling, and routine monitoring for HIV infection, laboratory abnormalities, and adverse events. TDF-FTC placebo: Placebo comparator for TDF-FTC
Overall Study Lost to Follow-up	52	63
Overall Study Withdrawal by Subject	90	74
Overall Study Relocated	49	36
Overall Study Were withdrawn by investigator	10	6
Overall Study Death	2	4
Overall Study Had other reasons	5	6
Overall Study HIV-infected at enrollment	1	2
Overall Study Never started drug	9	7

Baseline Characteristics

Botswana TDF/FTC Oral HIV Prophylaxis Trial

Baseline characteristics by cohort

Measure	TDF-FTC, Condoms, Risk Counseling n=611 Participants Participants randomized to the active arm received daily oral TDF-FTC along with male and female condoms, personalized risk reduction counseling, adherence counseling, and routine monitoring for HIV infection, laboratory abnormalities, and adverse events. Tenofovir Disoproxil Fumarate 300 mg + Emtricitabine 200 mg: Daily oral single dose pill containing 300 mg TDF and 200 mg FTC.	Placebo, Condoms, Risk Counseling n=608 Participants Participants randomized to the placebo arm received a daily oral placebo tablet along with male and female condoms, personalized risk reduction counseling, adherence counseling, and routine monitoring for HIV infection, laboratory abnormalities, and adverse events. TDF-FTC placebo: Placebo comparator for TDF-FTC	Total n=1219 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	611 Participants n=5 Participants	608 Participants n=7 Participants	1219 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	280 Participants n=5 Participants	277 Participants n=7 Participants	557 Participants n=5 Participants
Sex: Female, Male Male	331 Participants n=5 Participants	331 Participants n=7 Participants	662 Participants n=5 Participants
Region of Enrollment Botswana	611 participants n=5 Participants	608 participants n=7 Participants	1219 participants n=5 Participants

PRIMARY outcome

Timeframe: Monthly, for up to 3 years

Study visits were scheduled every 30 days until completion of the study, and participants were instructed to return to the clinic for evaluation in the event of an illness. Participants reported any adverse effects at monthly visits and interim visits.

Outcome measures

Measure	TDF-FTC, Condoms, Risk Counseling n=611 Participants Participants randomized to the active arm received daily oral TDF-FTC along with male and female condoms, personalized risk reduction counseling, adherence counseling, and routine monitoring for HIV infection, laboratory abnormalities, and adverse events. Tenofovir Disoproxil Fumarate 300 mg + Emtricitabine 200 mg: Daily oral single dose pill containing 300 mg TDF and 200 mg FTC.	Placebo, Condoms, Risk Counseling n=608 Participants Participants randomized to the placebo arm received a daily oral placebo tablet along with male and female condoms, personalized risk reduction counseling, adherence counseling, and routine monitoring for HIV infection, laboratory abnormalities, and adverse events. TDF-FTC placebo: Placebo comparator for TDF-FTC
Percentage of Participants With Adverse Drug Reactions in the Tenofovir/Emtricitabine and Placebo Arms	91.2 percentage of participants with AE	88.2 percentage of participants with AE

PRIMARY outcome

Timeframe: Monthly, for up to 3 years

Population: Of the 1219, 3 were excluded from analysis because HIV-infected at the time of enrollment.

Study visits were scheduled every 30 days until completion of the study and during monthly study visits, we performed testing for HIV infection. At completion of the study, we tested all participants for HIV infection, using an enzyme-linked immunosorbent assay (ELISA).The primary efficacy end point was the difference in the rates of HIV infection between participants assigned to receive TDF-FTC and those assigned to receive placebo. The initial efficacy analysis included all study participants who were randomly assigned to receive a study medication (intention-to-treat cohort).

Outcome measures

Measure	TDF-FTC, Condoms, Risk Counseling n=610 Participants Participants randomized to the active arm received daily oral TDF-FTC along with male and female condoms, personalized risk reduction counseling, adherence counseling, and routine monitoring for HIV infection, laboratory abnormalities, and adverse events. Tenofovir Disoproxil Fumarate 300 mg + Emtricitabine 200 mg: Daily oral single dose pill containing 300 mg TDF and 200 mg FTC.	Placebo, Condoms, Risk Counseling n=606 Participants Participants randomized to the placebo arm received a daily oral placebo tablet along with male and female condoms, personalized risk reduction counseling, adherence counseling, and routine monitoring for HIV infection, laboratory abnormalities, and adverse events. TDF-FTC placebo: Placebo comparator for TDF-FTC
HIV Incidence in the Tenofovir/Emtricitabine and Placebo Arms	1.2 infections/100 person-years	3.1 infections/100 person-years

SECONDARY outcome

Timeframe: 12 months

Population: Of 1219, 19 excluded (3 HIV-infected at enrollment, 16 never started drug). Of the 1200, 24 reported no sex during study. Remaining total 1176 with \>=1 sex act included in analysis.

We assessed condom use of the enrolled participants by face-to-face interviews (at baseline and monthly thereafter) and provided a comprehensive package of HIV prevention services, including individualized counseling on risk reduction, free male and female condoms, and screening for sexually transmitted infections followed, if applicable, by partner notification and treatment.

Outcome measures

Measure	TDF-FTC, Condoms, Risk Counseling n=611 Participants Participants randomized to the active arm received daily oral TDF-FTC along with male and female condoms, personalized risk reduction counseling, adherence counseling, and routine monitoring for HIV infection, laboratory abnormalities, and adverse events. Tenofovir Disoproxil Fumarate 300 mg + Emtricitabine 200 mg: Daily oral single dose pill containing 300 mg TDF and 200 mg FTC.	Placebo, Condoms, Risk Counseling n=608 Participants Participants randomized to the placebo arm received a daily oral placebo tablet along with male and female condoms, personalized risk reduction counseling, adherence counseling, and routine monitoring for HIV infection, laboratory abnormalities, and adverse events. TDF-FTC placebo: Placebo comparator for TDF-FTC
Changes in Condom Use During Study: Number of Participants With >=1 Condomless Sex Acts Baseline	124 Participants	113 Participants
Changes in Condom Use During Study: Number of Participants With >=1 Condomless Sex Acts Month 1	94 Participants	86 Participants
Changes in Condom Use During Study: Number of Participants With >=1 Condomless Sex Acts Month 2	97 Participants	90 Participants
Changes in Condom Use During Study: Number of Participants With >=1 Condomless Sex Acts Month 3	92 Participants	83 Participants
Changes in Condom Use During Study: Number of Participants With >=1 Condomless Sex Acts Month 4	73 Participants	66 Participants
Changes in Condom Use During Study: Number of Participants With >=1 Condomless Sex Acts Month 5	67 Participants	61 Participants
Changes in Condom Use During Study: Number of Participants With >=1 Condomless Sex Acts Month 6	70 Participants	67 Participants
Changes in Condom Use During Study: Number of Participants With >=1 Condomless Sex Acts Month 7	55 Participants	45 Participants
Changes in Condom Use During Study: Number of Participants With >=1 Condomless Sex Acts Month 8	57 Participants	49 Participants
Changes in Condom Use During Study: Number of Participants With >=1 Condomless Sex Acts Month 9	55 Participants	45 Participants
Changes in Condom Use During Study: Number of Participants With >=1 Condomless Sex Acts Month 10	51 Participants	36 Participants
Changes in Condom Use During Study: Number of Participants With >=1 Condomless Sex Acts Month 11	36 Participants	33 Participants
Changes in Condom Use During Study: Number of Participants With >=1 Condomless Sex Acts Month 12	54 Participants	30 Participants

SECONDARY outcome

Timeframe: 36 months

The rates of adherence to study medication by treatment arm was assessed over the entire course of the study. This comparison was done by assessing the percentage of pills taken by participants within each study arm. The difference between the 2 arms was compared with a Fisher' exact test.

Outcome measures

Measure	TDF-FTC, Condoms, Risk Counseling n=611 Participants Participants randomized to the active arm received daily oral TDF-FTC along with male and female condoms, personalized risk reduction counseling, adherence counseling, and routine monitoring for HIV infection, laboratory abnormalities, and adverse events. Tenofovir Disoproxil Fumarate 300 mg + Emtricitabine 200 mg: Daily oral single dose pill containing 300 mg TDF and 200 mg FTC.	Placebo, Condoms, Risk Counseling n=608 Participants Participants randomized to the placebo arm received a daily oral placebo tablet along with male and female condoms, personalized risk reduction counseling, adherence counseling, and routine monitoring for HIV infection, laboratory abnormalities, and adverse events. TDF-FTC placebo: Placebo comparator for TDF-FTC
Rates of Adherence to Study Medication	93.5 Percentage of pills taken Standard Deviation 0.136	93.6 Percentage of pills taken Standard Deviation 0.137

SECONDARY outcome

Timeframe: At time HIV infection diagnosed,1 month post-time of HIV infection diagnosis, and 6 months post-time of HIV infection diagnosis

Participants who seroconverted had blood samples taken at the time of infection and at one month and six months post seroconversion to detect any HIV resistance mutations.

Outcome measures

Measure	TDF-FTC, Condoms, Risk Counseling n=10 Participants Participants randomized to the active arm received daily oral TDF-FTC along with male and female condoms, personalized risk reduction counseling, adherence counseling, and routine monitoring for HIV infection, laboratory abnormalities, and adverse events. Tenofovir Disoproxil Fumarate 300 mg + Emtricitabine 200 mg: Daily oral single dose pill containing 300 mg TDF and 200 mg FTC.	Placebo, Condoms, Risk Counseling n=26 Participants Participants randomized to the placebo arm received a daily oral placebo tablet along with male and female condoms, personalized risk reduction counseling, adherence counseling, and routine monitoring for HIV infection, laboratory abnormalities, and adverse events. TDF-FTC placebo: Placebo comparator for TDF-FTC
Antiretroviral (ARV) Resistance Patterns in Seroconverters	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 1-year post seroconversion

Study medication was stopped when HIV infected was diagnosed. Seroconvertors were referred for clinical care and followed an additional year with scheduled quarterly CD4+ cell count assessments. A model-estimated geometric mean of the CD4+ cell counts by each treatment group was evaluated.

Outcome measures

Measure	TDF-FTC, Condoms, Risk Counseling n=9 Participants Participants randomized to the active arm received daily oral TDF-FTC along with male and female condoms, personalized risk reduction counseling, adherence counseling, and routine monitoring for HIV infection, laboratory abnormalities, and adverse events. Tenofovir Disoproxil Fumarate 300 mg + Emtricitabine 200 mg: Daily oral single dose pill containing 300 mg TDF and 200 mg FTC.	Placebo, Condoms, Risk Counseling n=24 Participants Participants randomized to the placebo arm received a daily oral placebo tablet along with male and female condoms, personalized risk reduction counseling, adherence counseling, and routine monitoring for HIV infection, laboratory abnormalities, and adverse events. TDF-FTC placebo: Placebo comparator for TDF-FTC
CD4 Evaluation After HIV Seroconversion	500 cells/microliter Interval 378.0 to 661.0	466 cells/microliter Interval 396.0 to 549.0

Adverse Events

TDF-FTC, Condoms, Risk Counseling

Serious events: 42 serious events

Other events: 557 other events

Deaths: 0 deaths

Placebo, Condoms, Risk Counseling

Serious events: 44 serious events

Other events: 536 other events

Deaths: 0 deaths

Serious adverse events

Measure	TDF-FTC, Condoms, Risk Counseling n=611 participants at risk Participants randomized to the active arm received daily oral TDF-FTC along with male and female condoms, personalized risk reduction counseling, adherence counseling, and routine monitoring for HIV infection, laboratory abnormalities, and adverse events. Tenofovir Disoproxil Fumarate 300 mg + Emtricitabine 200 mg: Daily oral single dose pill containing 300 mg TDF and 200 mg FTC.	Placebo, Condoms, Risk Counseling n=608 participants at risk Participants randomized to the placebo arm received a daily oral placebo tablet along with male and female condoms, personalized risk reduction counseling, adherence counseling, and routine monitoring for HIV infection, laboratory abnormalities, and adverse events. TDF-FTC placebo: Placebo comparator for TDF-FTC
Hepatobiliary disorders Elevated ALT	0.16% 1/611 • Number of events 1 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	0.00% 0/608 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Endocrine disorders Hyperamylasemia	1.5% 9/611 • Number of events 11 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	1.5% 9/608 • Number of events 18 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
General disorders Hyperchloremia	0.16% 1/611 • Number of events 1 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	0.16% 1/608 • Number of events 1 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Renal and urinary disorders Elevated creatinine	0.16% 1/611 • Number of events 1 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	0.00% 0/608 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Renal and urinary disorders Hypophosphatemia	3.3% 20/611 • Number of events 21 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	3.5% 21/608 • Number of events 24 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Renal and urinary disorders Hyperkalemia	0.00% 0/611 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	0.16% 1/608 • Number of events 1 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Renal and urinary disorders Hypernatremia	0.16% 1/611 • Number of events 1 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	0.16% 1/608 • Number of events 1 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Cardiac disorders Chest Pain	0.00% 0/611 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	0.16% 1/608 • Number of events 1 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Gastrointestinal disorders Constipation	0.16% 1/611 • Number of events 1 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	0.00% 0/608 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Musculoskeletal and connective tissue disorders Fracture	0.33% 2/611 • Number of events 2 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	0.16% 1/608 • Number of events 2 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
General disorders Headache	0.33% 2/611 • Number of events 2 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	0.16% 1/608 • Number of events 1 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Musculoskeletal and connective tissue disorders Injury, non-fatal	0.16% 1/611 • Number of events 1 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	0.66% 4/608 • Number of events 4 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Gastrointestinal disorders Abdominal pain	0.16% 1/611 • Number of events 1 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	0.00% 0/608 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Infections and infestations Tonsillitis, acute	0.16% 1/611 • Number of events 1 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	0.16% 1/608 • Number of events 1 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Skin and subcutaneous tissue disorders Wound	0.16% 1/611 • Number of events 1 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	0.33% 2/608 • Number of events 3 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/611 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	0.16% 1/608 • Number of events 1 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).

Other adverse events

Measure	TDF-FTC, Condoms, Risk Counseling n=611 participants at risk Participants randomized to the active arm received daily oral TDF-FTC along with male and female condoms, personalized risk reduction counseling, adherence counseling, and routine monitoring for HIV infection, laboratory abnormalities, and adverse events. Tenofovir Disoproxil Fumarate 300 mg + Emtricitabine 200 mg: Daily oral single dose pill containing 300 mg TDF and 200 mg FTC.	Placebo, Condoms, Risk Counseling n=608 participants at risk Participants randomized to the placebo arm received a daily oral placebo tablet along with male and female condoms, personalized risk reduction counseling, adherence counseling, and routine monitoring for HIV infection, laboratory abnormalities, and adverse events. TDF-FTC placebo: Placebo comparator for TDF-FTC
Reproductive system and breast disorders Abnormal Menses	8.8% 54/611 • Number of events 68 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	10.5% 64/608 • Number of events 79 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Gastrointestinal disorders Bilirubin, direct	2.8% 17/611 • Number of events 19 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	2.8% 17/608 • Number of events 25 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Skin and subcutaneous tissue disorders Abscess	2.1% 13/611 • Number of events 13 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	2.8% 17/608 • Number of events 18 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Skin and subcutaneous tissue disorders Acne	1.8% 11/611 • Number of events 11 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	0.82% 5/608 • Number of events 5 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
General disorders Allergy, unspecified	1.5% 9/611 • Number of events 9 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	0.99% 6/608 • Number of events 6 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Gastrointestinal disorders Anorexia	2.8% 17/611 • Number of events 17 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	2.5% 15/608 • Number of events 16 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Reproductive system and breast disorders Balanitis	0.98% 6/611 • Number of events 6 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	1.3% 8/608 • Number of events 11 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Injury, poisoning and procedural complications Bite	0.82% 5/611 • Number of events 6 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	1.6% 10/608 • Number of events 11 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Reproductive system and breast disorders Breast Abnormalities	1.1% 7/611 • Number of events 7 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	1.6% 10/608 • Number of events 10 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Cardiac disorders Chest Pain	4.6% 28/611 • Number of events 34 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	6.4% 39/608 • Number of events 44 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Reproductive system and breast disorders Chlamydia	12.4% 76/611 • Number of events 85 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	12.3% 75/608 • Number of events 83 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Infections and infestations Upper Respiratory Infection	37.8% 231/611 • Number of events 385 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	39.6% 241/608 • Number of events 439 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Eye disorders Conjuctivitis	3.3% 20/611 • Number of events 20 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	3.3% 20/608 • Number of events 22 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Gastrointestinal disorders Constipation	4.7% 29/611 • Number of events 33 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	3.8% 23/608 • Number of events 24 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Skin and subcutaneous tissue disorders Contusion	1.3% 8/611 • Number of events 10 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	1.2% 7/608 • Number of events 9 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Respiratory, thoracic and mediastinal disorders Cough	5.1% 31/611 • Number of events 36 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	6.4% 39/608 • Number of events 44 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Skin and subcutaneous tissue disorders Dermatitis	1.3% 8/611 • Number of events 8 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	1.2% 7/608 • Number of events 7 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Skin and subcutaneous tissue disorders Dermatomycosis	2.3% 14/611 • Number of events 14 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	0.82% 5/608 • Number of events 6 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Skin and subcutaneous tissue disorders Dermatophytosis	5.6% 34/611 • Number of events 35 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	3.9% 24/608 • Number of events 26 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Gastrointestinal disorders Diarrhea	12.4% 76/611 • Number of events 93 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	10.7% 65/608 • Number of events 76 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Skin and subcutaneous tissue disorders Disturbance of Skin Sensation	1.5% 9/611 • Number of events 9 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	0.49% 3/608 • Number of events 3 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Nervous system disorders Dizziness	15.1% 92/611 • Number of events 109 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	10.7% 65/608 • Number of events 80 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Reproductive system and breast disorders Dysmenorrhea	5.2% 32/611 • Number of events 47 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	5.6% 34/608 • Number of events 46 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Renal and urinary disorders Dysuria	2.8% 17/611 • Number of events 24 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	3.9% 24/608 • Number of events 29 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Skin and subcutaneous tissue disorders Edema, limb	0.65% 4/611 • Number of events 4 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	1.2% 7/608 • Number of events 8 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
General disorders Epistaxis	0.98% 6/611 • Number of events 7 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	1.3% 8/608 • Number of events 8 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
General disorders Fatigue	8.7% 53/611 • Number of events 55 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	7.4% 45/608 • Number of events 48 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
General disorders Fever	1.8% 11/611 • Number of events 11 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	1.8% 11/608 • Number of events 11 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Gastrointestinal disorders Flatulence	9.2% 56/611 • Number of events 67 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	9.5% 58/608 • Number of events 63 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Skin and subcutaneous tissue disorders Folliculitis	0.65% 4/611 • Number of events 4 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	1.6% 10/608 • Number of events 10 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Musculoskeletal and connective tissue disorders Fracture	0.49% 3/611 • Number of events 3 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	0.49% 3/608 • Number of events 4 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Gastrointestinal disorders Gastroesophageal Reflux	1.5% 9/611 • Number of events 12 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	0.66% 4/608 • Number of events 4 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
General disorders Generalized Pain	1.8% 11/611 • Number of events 11 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	0.99% 6/608 • Number of events 6 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Reproductive system and breast disorders Genital Herpes	4.6% 28/611 • Number of events 43 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	5.8% 35/608 • Number of events 46 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Reproductive system and breast disorders Gonorrhea	4.6% 28/611 • Number of events 32 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	3.0% 18/608 • Number of events 21 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
General disorders Headache	36.8% 225/611 • Number of events 384 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	37.0% 225/608 • Number of events 410 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Cardiac disorders Hypertension	0.98% 6/611 • Number of events 6 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	2.1% 13/608 • Number of events 13 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Cardiac disorders Hypotension	1.1% 7/611 • Number of events 7 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	0.49% 3/608 • Number of events 3 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Injury, poisoning and procedural complications Injury, Nonfatal	2.1% 13/611 • Number of events 13 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	2.5% 15/608 • Number of events 18 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Reproductive system and breast disorders Leukorrhea	4.9% 30/611 • Number of events 39 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	8.7% 53/608 • Number of events 64 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Musculoskeletal and connective tissue disorders Myalgia	2.8% 17/611 • Number of events 19 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	3.8% 23/608 • Number of events 25 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Gastrointestinal disorders Nausea	18.5% 113/611 • Number of events 132 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	7.1% 43/608 • Number of events 48 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
General disorders Oral Disease, Gingiva	1.6% 10/611 • Number of events 11 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	0.66% 4/608 • Number of events 4 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
General disorders Oral Disease, Teeth	5.4% 33/611 • Number of events 43 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	6.6% 40/608 • Number of events 51 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Ear and labyrinth disorders Pain, Ear	0.49% 3/611 • Number of events 3 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	1.6% 10/608 • Number of events 10 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Gastrointestinal disorders Pain, Abdominal	25.2% 154/611 • Number of events 214 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	25.7% 156/608 • Number of events 217 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Musculoskeletal and connective tissue disorders Pain, Acute Musculoskeletal	1.3% 8/611 • Number of events 8 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	1.2% 7/608 • Number of events 8 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Musculoskeletal and connective tissue disorders Pain, Back	9.3% 57/611 • Number of events 72 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	11.0% 67/608 • Number of events 89 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Reproductive system and breast disorders Pain, Genital	1.1% 7/611 • Number of events 8 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	1.3% 8/608 • Number of events 9 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Musculoskeletal and connective tissue disorders Pain, Joint	4.6% 28/611 • Number of events 34 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	3.8% 23/608 • Number of events 27 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Musculoskeletal and connective tissue disorders Pain, Limb	3.4% 21/611 • Number of events 24 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	4.6% 28/608 • Number of events 31 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Eye disorders Painful Eyes	1.1% 7/611 • Number of events 8 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	1.3% 8/608 • Number of events 9 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Cardiac disorders Palpitations	2.9% 18/611 • Number of events 21 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	2.5% 15/608 • Number of events 20 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Reproductive system and breast disorders Pelvic Inflammatory Disease	1.1% 7/611 • Number of events 9 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	1.8% 11/608 • Number of events 12 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
General disorders Pharyngitis, Acute	6.4% 39/611 • Number of events 45 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	6.1% 37/608 • Number of events 38 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Endocrine disorders Polyphagia	5.7% 35/611 • Number of events 38 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	4.9% 30/608 • Number of events 33 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Reproductive system and breast disorders Pruritus, Genital	2.5% 15/611 • Number of events 16 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	3.1% 19/608 • Number of events 20 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Skin and subcutaneous tissue disorders Pruritus, Unspecified	2.0% 12/611 • Number of events 12 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	2.0% 12/608 • Number of events 12 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Skin and subcutaneous tissue disorders Rash, Unspecified	6.4% 39/611 • Number of events 44 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	6.9% 42/608 • Number of events 48 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
General disorders Rhinitis	0.98% 6/611 • Number of events 7 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	1.2% 7/608 • Number of events 7 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Respiratory, thoracic and mediastinal disorders Shortness of Breath	0.82% 5/611 • Number of events 5 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	2.0% 12/608 • Number of events 14 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Reproductive system and breast disorders Sore Ulcer, Genital	2.0% 12/611 • Number of events 12 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	0.99% 6/608 • Number of events 7 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Skin and subcutaneous tissue disorders Sore Ulcer, Oral Cavity	1.5% 9/611 • Number of events 11 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	0.82% 5/608 • Number of events 5 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
General disorders Tonsilitis, Acute	3.9% 24/611 • Number of events 28 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	3.9% 24/608 • Number of events 24 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Reproductive system and breast disorders Trichomoniasis	3.3% 20/611 • Number of events 21 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	3.0% 18/608 • Number of events 23 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Reproductive system and breast disorders Urethral Discharge	0.33% 2/611 • Number of events 2 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	1.8% 11/608 • Number of events 15 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Renal and urinary disorders Urinary Tract Infection	1.3% 8/611 • Number of events 10 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	1.5% 9/608 • Number of events 9 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Reproductive system and breast disorders Vaginal Candidiasis	6.2% 38/611 • Number of events 42 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	4.6% 28/608 • Number of events 37 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Gastrointestinal disorders Vomiting	11.3% 69/611 • Number of events 87 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	7.1% 43/608 • Number of events 47 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Skin and subcutaneous tissue disorders Wound	5.4% 33/611 • Number of events 37 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	5.6% 34/608 • Number of events 40 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Renal and urinary disorders Blood Urea Nitrogen	0.33% 2/611 • Number of events 2 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	0.16% 1/608 • Number of events 1 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Blood and lymphatic system disorders Phosphate	20.0% 122/611 • Number of events 198 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	22.7% 138/608 • Number of events 221 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Gastrointestinal disorders Amylase, Serum	50.1% 306/611 • Number of events 986 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	48.2% 293/608 • Number of events 999 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Gastrointestinal disorders AST/SGOT	5.9% 36/611 • Number of events 43 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	6.2% 38/608 • Number of events 42 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Gastrointestinal disorders ALT/SGPT	6.1% 37/611 • Number of events 47 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	7.1% 43/608 • Number of events 66 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Blood and lymphatic system disorders Bilirubin, total	6.7% 41/611 • Number of events 70 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	6.4% 39/608 • Number of events 73 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Blood and lymphatic system disorders Sodium	20.6% 126/611 • Number of events 172 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	18.6% 113/608 • Number of events 148 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Blood and lymphatic system disorders Potassium	3.9% 24/611 • Number of events 27 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	3.6% 22/608 • Number of events 25 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Blood and lymphatic system disorders Bicarbonate	0.98% 6/611 • Number of events 6 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	0.99% 6/608 • Number of events 6 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).
Blood and lymphatic system disorders Chloride	4.1% 25/611 • Number of events 30 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).	3.5% 21/608 • Number of events 23 • Adverse event data were collected throughout the course of the study until study completion, i.e. up to 3 years. Adverse events were graded according to the National Institutes of Health Division of AIDS (DAIDS) Table for Grading Severity of Adult and Pediatric Adverse Events (December 2004).

Additional Information

Dr. Michael Thigpen

National Institutes of Health

Phone: 1-240-669-2877

Email: michael.thigpen@nih.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place