Trial Outcomes & Findings for Emtricitabine/Tenofovir Disoproxil Fumarate for HIV Prevention in Men (NCT NCT00458393)
NCT ID: NCT00458393
Last Updated: 2021-11-02
Results Overview
Confirmed HIV infection
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2499 participants
Primary outcome timeframe
Monthly follow-up through a median of 1.2 years
Results posted on
2021-11-02
Participant Flow
The study recruited HIV uninfected participants whose sexual practices put them at risk for HIV infection. They were recruited from community clinics.
Participant milestones
| Measure |
TDF/FTC
Daily oral emtricitabine/tenofovir disoproxil fumarate
Emtricitabine/tenofovir disoproxil fumarate: Fixed-dose coformulation of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate
|
Placebo
Daily oral placebo
Placebo: Placebo for emtricitabine/tenofovir disoproxil fumarate
|
|---|---|---|
|
Overall Study
STARTED
|
1251
|
1248
|
|
Overall Study
COMPLETED
|
942
|
953
|
|
Overall Study
NOT COMPLETED
|
309
|
295
|
Reasons for withdrawal
| Measure |
TDF/FTC
Daily oral emtricitabine/tenofovir disoproxil fumarate
Emtricitabine/tenofovir disoproxil fumarate: Fixed-dose coformulation of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate
|
Placebo
Daily oral placebo
Placebo: Placebo for emtricitabine/tenofovir disoproxil fumarate
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
67
|
80
|
|
Overall Study
Physician Decision
|
31
|
22
|
|
Overall Study
Relocated
|
77
|
81
|
|
Overall Study
Lost to Follow-up
|
115
|
92
|
|
Overall Study
Sites marked other on the form.
|
19
|
20
|
Baseline Characteristics
Emtricitabine/Tenofovir Disoproxil Fumarate for HIV Prevention in Men
Baseline characteristics by cohort
| Measure |
TDF/FTC
n=1251 Participants
Daily oral emtricitabine/tenofovir disoproxil fumarate
Emtricitabine/tenofovir disoproxil fumarate: Fixed-dose coformulation of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate
|
Placebo
n=1248 Participants
Daily oral placebo
Placebo: Placebo for emtricitabine/tenofovir disoproxil fumarate
|
Total
n=2499 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
92 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
193 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1158 Participants
n=5 Participants
|
1147 Participants
n=7 Participants
|
2305 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
25 years
n=5 Participants
|
24 years
n=7 Participants
|
24 years
n=5 Participants
|
|
Sex/Gender, Customized
Male Sex at Birth. Identify Trans
|
155 Participants
n=5 Participants
|
155 Participants
n=7 Participants
|
310 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male Sex at Birth. Identify Female
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male Sex at Birth. Identify Male
|
1081 Participants
n=5 Participants
|
1079 Participants
n=7 Participants
|
2160 Participants
n=5 Participants
|
|
Region of Enrollment
Ecuador
|
150 participants
n=5 Participants
|
150 participants
n=7 Participants
|
300 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
113 participants
n=5 Participants
|
114 participants
n=7 Participants
|
227 participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
186 participants
n=5 Participants
|
184 participants
n=7 Participants
|
370 participants
n=5 Participants
|
|
Region of Enrollment
South Africa
|
45 participants
n=5 Participants
|
43 participants
n=7 Participants
|
88 participants
n=5 Participants
|
|
Region of Enrollment
Thailand
|
57 participants
n=5 Participants
|
57 participants
n=7 Participants
|
114 participants
n=5 Participants
|
|
Region of Enrollment
Peru
|
700 participants
n=5 Participants
|
700 participants
n=7 Participants
|
1400 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Monthly follow-up through a median of 1.2 yearsPopulation: Excludes participants who were HIV+ at enrollment (2 TDF/FTC, 8 Placebo) and those with no follow-up HIV test (25 TDF/FTC and 22 Placebo).
Confirmed HIV infection
Outcome measures
| Measure |
TDF/FTC
n=1224 Participants
Daily oral emtricitabine/tenofovir disoproxil fumarate
Emtricitabine/tenofovir disoproxil fumarate: Fixed-dose coformulation of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate
|
Placebo
n=1218 Participants
Daily oral placebo
Placebo: Placebo for emtricitabine/tenofovir disoproxil fumarate
|
|---|---|---|
|
HIV Seroconversion
|
48 Participants
|
83 Participants
|
PRIMARY outcome
Timeframe: Duration of follow-up, median 1.2 yearsPopulation: All randomized participants which at least 1 follow-up creatinine value
Creatinine which reach grade 1 (mild, 1.1 to 1.3 local upper limit of normal) or higher by the US Division of AIDS grading table (version 1) or a 50% increase in creatinine from the baseline value. The DAIDS table can be found at https://rsc.tech-res.com/docs/default-source/safety/table\_for\_grading\_severity\_of\_adult\_pediatric\_adverse\_events.pdf
Outcome measures
| Measure |
TDF/FTC
n=1216 Participants
Daily oral emtricitabine/tenofovir disoproxil fumarate
Emtricitabine/tenofovir disoproxil fumarate: Fixed-dose coformulation of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate
|
Placebo
n=1217 Participants
Daily oral placebo
Placebo: Placebo for emtricitabine/tenofovir disoproxil fumarate
|
|---|---|---|
|
Grade 1 or Higher Creatinine Toxicity
|
32 Participants
|
24 Participants
|
PRIMARY outcome
Timeframe: The entire follow-up period, median 1.2 yearsPopulation: All participants with at least 1 follow-up phosphorus value
Grade 3 or higher phosphorous toxicity (hypophosphatemia) by the Division of AIDS Grading Table (severe, level at or below 1.9 mg/dL)
Outcome measures
| Measure |
TDF/FTC
n=1225 Participants
Daily oral emtricitabine/tenofovir disoproxil fumarate
Emtricitabine/tenofovir disoproxil fumarate: Fixed-dose coformulation of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate
|
Placebo
n=1226 Participants
Daily oral placebo
Placebo: Placebo for emtricitabine/tenofovir disoproxil fumarate
|
|---|---|---|
|
Grade 3 or Higher Phosphorous Toxicity
|
13 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: Entire follow-up, median 1.2 yearsPopulation: At participants with at least one visit with laboratory values post-baseline
Number of participants with at least one Grade 2, 3, or 4 laboratory adverse events (moderate, severe of life threatening based one the US Division of AIDS Grading of adverse events, version 1.0). The table can be found at https://rsc.tech-res.com/docs/default-source/safety/table\_for\_grading\_severity\_of\_adult\_pediatric\_adverse\_events.pdf
Outcome measures
| Measure |
TDF/FTC
n=1229 Participants
Daily oral emtricitabine/tenofovir disoproxil fumarate
Emtricitabine/tenofovir disoproxil fumarate: Fixed-dose coformulation of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate
|
Placebo
n=1226 Participants
Daily oral placebo
Placebo: Placebo for emtricitabine/tenofovir disoproxil fumarate
|
|---|---|---|
|
Grade 2, 3, or 4 Laboratory Adverse Events
|
70 Participants
|
79 Participants
|
PRIMARY outcome
Timeframe: Entire follow-up, median 1.2 yearsPopulation: At participants with at least one follow-up visit
Number of participants with at least 1 Grade 2, 3, or 4 clinical adverse events (moderate, severe of life threatening based one the US Division of AIDS Grading of adverse events, version 1.0). The table can be found at https://rsc.tech-res.com/docs/default-source/safety/table\_for\_grading\_severity\_of\_adult\_pediatric\_adverse\_events.pdf
Outcome measures
| Measure |
TDF/FTC
n=1226 Participants
Daily oral emtricitabine/tenofovir disoproxil fumarate
Emtricitabine/tenofovir disoproxil fumarate: Fixed-dose coformulation of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate
|
Placebo
n=1230 Participants
Daily oral placebo
Placebo: Placebo for emtricitabine/tenofovir disoproxil fumarate
|
|---|---|---|
|
Grade 2, 3, or 4 Clinical Adverse Events
|
157 Participants
|
162 Participants
|
SECONDARY outcome
Timeframe: Quarterly lab tests through a median follow-up of 1.2 yearsPopulation: Those with chronic active hepatitis B at enrollment.
A hepatic flare is defined as an increase in alanine transaminase or aspartate transaminase to \>5 fold upper limit of normal at any visit, or an increase to \>2.5 fold upper limit of normal for 3 months, within 24 weeks of permanently stopping study drug. More details in https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4752387/
Outcome measures
| Measure |
TDF/FTC
n=6 Participants
Daily oral emtricitabine/tenofovir disoproxil fumarate
Emtricitabine/tenofovir disoproxil fumarate: Fixed-dose coformulation of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate
|
Placebo
n=6 Participants
Daily oral placebo
Placebo: Placebo for emtricitabine/tenofovir disoproxil fumarate
|
|---|---|---|
|
Hepatitis Flares Among Hepatitis B Virus (HBV) Infected Persons During and After Chemoprophylaxis
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: baseline and week 24.Population: Participants confirmed to be HIV negative at enrollment who consented to participate in the metabolic substudy. Full details in https://www.ncbi.nlm.nih.gov/pmc/articles/pmid/25908682/
% Change from baseline in bone mineral density (100 \* \[(value at 24 weeks- value at baseline)/ (value at baseline)\]) in in hip and L1-L4 spine by dual-energy x-ray absorptiometry
Outcome measures
| Measure |
TDF/FTC
n=210 Participants
Daily oral emtricitabine/tenofovir disoproxil fumarate
Emtricitabine/tenofovir disoproxil fumarate: Fixed-dose coformulation of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate
|
Placebo
n=211 Participants
Daily oral placebo
Placebo: Placebo for emtricitabine/tenofovir disoproxil fumarate
|
|---|---|---|
|
Percentage Change in Bone Mineral Density
L1-L4 Spine bone mineral density
|
-0.59 percent change from baseline
Standard Error 0.21
|
0.32 percent change from baseline
Standard Error 0.21
|
|
Percentage Change in Bone Mineral Density
Hip bone mineral density
|
-0.34 percent change from baseline
Standard Error 0.16
|
0.29 percent change from baseline
Standard Error 0.16
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: All participants in the body composition substudy who made a week 24 body scan
Percentage Change (100 \* \[(value at 24 weeks- value at baseline)/ (value at baseline)\]) in Body Fat from Baseline by dual-energy x-ray absorptiometry
Outcome measures
| Measure |
TDF/FTC
n=210 Participants
Daily oral emtricitabine/tenofovir disoproxil fumarate
Emtricitabine/tenofovir disoproxil fumarate: Fixed-dose coformulation of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate
|
Placebo
n=211 Participants
Daily oral placebo
Placebo: Placebo for emtricitabine/tenofovir disoproxil fumarate
|
|---|---|---|
|
Percentage Change in Body Fat
|
0.0 percent change from baseline
Standard Error 1.0
|
3.8 percent change from baseline
Standard Error 1.0
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: All participants in the metabolic substudy with a week 24 fast triglyceride value
Percentage Change (Percentage Change (100 \* \[(value at 24 weeks- value at baseline)/ (value at baseline)\]) in Triglycerides from Baseline from a fasting sample.
Outcome measures
| Measure |
TDF/FTC
n=199 Participants
Daily oral emtricitabine/tenofovir disoproxil fumarate
Emtricitabine/tenofovir disoproxil fumarate: Fixed-dose coformulation of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate
|
Placebo
n=194 Participants
Daily oral placebo
Placebo: Placebo for emtricitabine/tenofovir disoproxil fumarate
|
|---|---|---|
|
Percentage Change in Fasting Triglycerides
|
0.0 percent change from baseline
Standard Error 3.3
|
0.0 percent change from baseline
Standard Error 3.4
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: All participants in the metabolic substudy with a week 24 fasting cholesterol
Percent change (100 \* \[(value at 24 weeks- value at baseline)/ (value at baseline)\]) in fasting total cholesterol from baseline
Outcome measures
| Measure |
TDF/FTC
n=199 Participants
Daily oral emtricitabine/tenofovir disoproxil fumarate
Emtricitabine/tenofovir disoproxil fumarate: Fixed-dose coformulation of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate
|
Placebo
n=194 Participants
Daily oral placebo
Placebo: Placebo for emtricitabine/tenofovir disoproxil fumarate
|
|---|---|---|
|
Percent Change in Total Cholesterol
|
-3.2 percent change from baseline
Standard Error 1.2
|
-1.1 percent change from baseline
Standard Error 1.2
|
SECONDARY outcome
Timeframe: At the time closest to HIV detectionPopulation: All HIV infections detected during the study including prior to, during and after study treatment
HIV-RNA in log10 units among HIV infected participants at the time closest to HIV detection
Outcome measures
| Measure |
TDF/FTC
n=54 Participants
Daily oral emtricitabine/tenofovir disoproxil fumarate
Emtricitabine/tenofovir disoproxil fumarate: Fixed-dose coformulation of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate
|
Placebo
n=93 Participants
Daily oral placebo
Placebo: Placebo for emtricitabine/tenofovir disoproxil fumarate
|
|---|---|---|
|
Viral Load Among HIV Infected Participants
|
5.2 log RNA copies per ml
Standard Error 0.11
|
5.1 log RNA copies per ml
Standard Error 0.08
|
SECONDARY outcome
Timeframe: at the time of HIV acquisitionPopulation: There were 2 TDF/FTC seroconversions at enrollment and 48 during follow-up. There were 8 Placebo seroconversions at enrollment and 83 during follow-up.
Genotypic resistance by clinical assays among the seroconverters from baseline to the end of the study treatment period
Outcome measures
| Measure |
TDF/FTC
n=50 Participants
Daily oral emtricitabine/tenofovir disoproxil fumarate
Emtricitabine/tenofovir disoproxil fumarate: Fixed-dose coformulation of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate
|
Placebo
n=91 Participants
Daily oral placebo
Placebo: Placebo for emtricitabine/tenofovir disoproxil fumarate
|
|---|---|---|
|
Among HIV Infected Participants Drug Resistance
Infected at Enrollment (prior to randomization)
|
2 Participants
|
1 Participants
|
|
Among HIV Infected Participants Drug Resistance
Infected after Randomization
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: at the time infection was detectedPopulation: HIV infected participants during the trial including those HIV+ at baseline
CD4 cell count for HIV infected participants during the trial
Outcome measures
| Measure |
TDF/FTC
n=51 Participants
Daily oral emtricitabine/tenofovir disoproxil fumarate
Emtricitabine/tenofovir disoproxil fumarate: Fixed-dose coformulation of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate
|
Placebo
n=87 Participants
Daily oral placebo
Placebo: Placebo for emtricitabine/tenofovir disoproxil fumarate
|
|---|---|---|
|
CD4 Count Among HIV Infected Participants
|
495 cells per cubic mm
Interval 470.0 to 520.0
|
502 cells per cubic mm
Interval 483.0 to 521.0
|
SECONDARY outcome
Timeframe: At 24 weeksPopulation: Those who bottles returned at the week 24 visit.
Estimated proportion of missed doses by pill count (assuming pills taken in unreturned bottles)
Outcome measures
| Measure |
TDF/FTC
n=983 Participants
Daily oral emtricitabine/tenofovir disoproxil fumarate
Emtricitabine/tenofovir disoproxil fumarate: Fixed-dose coformulation of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate
|
Placebo
n=999 Participants
Daily oral placebo
Placebo: Placebo for emtricitabine/tenofovir disoproxil fumarate
|
|---|---|---|
|
Proportion of Missed Doses by Pill Count
|
0.92 proportion of pills not returned
Interval 0.91 to 0.93
|
0.93 proportion of pills not returned
Interval 0.92 to 0.94
|
SECONDARY outcome
Timeframe: Week 24Population: All participants who answered the adherence question with an estimated adherence on the week 24 computer assisted structured interview
Percentage of missed doses by estimate during computer assisted structured interview
Outcome measures
| Measure |
TDF/FTC
n=884 Participants
Daily oral emtricitabine/tenofovir disoproxil fumarate
Emtricitabine/tenofovir disoproxil fumarate: Fixed-dose coformulation of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate
|
Placebo
n=902 Participants
Daily oral placebo
Placebo: Placebo for emtricitabine/tenofovir disoproxil fumarate
|
|---|---|---|
|
Percentage of Missed Doses by Estimate During CASI Interview
|
91.0 percentage of doses taken
Standard Error 0.5
|
91.2 percentage of doses taken
Standard Error 0.50
|
SECONDARY outcome
Timeframe: At 24 weeksPopulation: Participants interviewed about sexual practices at week 24
Participants self-report of the number of sexual partners with HIV positive or unknown status in the previous 12 weeks with whom they had condomless anal sex
Outcome measures
| Measure |
TDF/FTC
n=1091 Participants
Daily oral emtricitabine/tenofovir disoproxil fumarate
Emtricitabine/tenofovir disoproxil fumarate: Fixed-dose coformulation of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate
|
Placebo
n=1114 Participants
Daily oral placebo
Placebo: Placebo for emtricitabine/tenofovir disoproxil fumarate
|
|---|---|---|
|
Number of Condomless Sexual Partners With HIV Positive or Unknown Status
|
0 count
Interval 0.0 to 0.0
|
0 count
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Participants interviewed about sexual practices at week 24
Self-reported total number of sexual partners in the previous 12 weeks.
Outcome measures
| Measure |
TDF/FTC
n=1091 Participants
Daily oral emtricitabine/tenofovir disoproxil fumarate
Emtricitabine/tenofovir disoproxil fumarate: Fixed-dose coformulation of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate
|
Placebo
n=1114 Participants
Daily oral placebo
Placebo: Placebo for emtricitabine/tenofovir disoproxil fumarate
|
|---|---|---|
|
Total Number of Sexual Partners
|
3 Count
Interval 1.0 to 6.0
|
3 Count
Interval 1.0 to 7.0
|
SECONDARY outcome
Timeframe: At 24 weeksPopulation: Participants interviewed about sexual practices at week 24
Self-reported condomless receptive anal intercourse in the previous 12 weeks with any partners regardless of status.
Outcome measures
| Measure |
TDF/FTC
n=1091 Participants
Daily oral emtricitabine/tenofovir disoproxil fumarate
Emtricitabine/tenofovir disoproxil fumarate: Fixed-dose coformulation of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate
|
Placebo
n=1114 Participants
Daily oral placebo
Placebo: Placebo for emtricitabine/tenofovir disoproxil fumarate
|
|---|---|---|
|
Condomless Receptive Anal Intercourse in the Previous 12 Weeks With Any Partners Regardless of Status.
|
332 Participants
|
348 Participants
|
SECONDARY outcome
Timeframe: All Follow-Up median of 1.2 years of follow-upPopulation: Participants without active syphilis at baseline with a follow-up syphilis test.
Number of participants who have at least 1 confirmed syphilis infection during the study
Outcome measures
| Measure |
TDF/FTC
n=1155 Participants
Daily oral emtricitabine/tenofovir disoproxil fumarate
Emtricitabine/tenofovir disoproxil fumarate: Fixed-dose coformulation of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate
|
Placebo
n=1171 Participants
Daily oral placebo
Placebo: Placebo for emtricitabine/tenofovir disoproxil fumarate
|
|---|---|---|
|
Incidence of Confirmed Syphilis During Follow-Up
|
147 Participants
|
132 Participants
|
SECONDARY outcome
Timeframe: Total study follow-up, a median of 1.2 yearsPopulation: All HSV-2 negative participants with a follow-up HSV-2 test.
Incidence of HSV-2 during the follow-up period among those HIV-2 negative at baseline
Outcome measures
| Measure |
TDF/FTC
n=671 Participants
Daily oral emtricitabine/tenofovir disoproxil fumarate
Emtricitabine/tenofovir disoproxil fumarate: Fixed-dose coformulation of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate
|
Placebo
n=676 Participants
Daily oral placebo
Placebo: Placebo for emtricitabine/tenofovir disoproxil fumarate
|
|---|---|---|
|
Incidence of HSV-2 During the Follow-up Period
|
65 Participants
|
60 Participants
|
SECONDARY outcome
Timeframe: All of follow-up period, median of 1.2 yearsPopulation: All participants with at least one follow-up test for gonorrhea
Diagnosis of gonorrhea during the follow-up period by PCR
Outcome measures
| Measure |
TDF/FTC
n=1226 Participants
Daily oral emtricitabine/tenofovir disoproxil fumarate
Emtricitabine/tenofovir disoproxil fumarate: Fixed-dose coformulation of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate
|
Placebo
n=1229 Participants
Daily oral placebo
Placebo: Placebo for emtricitabine/tenofovir disoproxil fumarate
|
|---|---|---|
|
Diagnosis of Gonorrhea During the Follow-up Period
|
18 Participants
|
30 Participants
|
Adverse Events
TDF/FTC
Serious events: 92 serious events
Other events: 906 other events
Deaths: 0 deaths
Placebo
Serious events: 94 serious events
Other events: 937 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TDF/FTC
n=1226 participants at risk
Daily oral emtricitabine/tenofovir disoproxil fumarate
Emtricitabine/tenofovir disoproxil fumarate: Fixed-dose coformulation of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate
|
Placebo
n=1230 participants at risk
Daily oral placebo
Placebo: Placebo for emtricitabine/tenofovir disoproxil fumarate
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Bone Fracture
|
0.65%
8/1226 • Number of events 8 • Monthly follow-up with quarterly lab assessments though a median of 1.2 years of follow-up
Adverse events graded by the NIH Division of AIDS grading tables, version 1.0
|
0.73%
9/1230 • Number of events 9 • Monthly follow-up with quarterly lab assessments though a median of 1.2 years of follow-up
Adverse events graded by the NIH Division of AIDS grading tables, version 1.0
|
|
Blood and lymphatic system disorders
CREATININE INCREASE
|
0.73%
9/1226 • Number of events 9 • Monthly follow-up with quarterly lab assessments though a median of 1.2 years of follow-up
Adverse events graded by the NIH Division of AIDS grading tables, version 1.0
|
0.57%
7/1230 • Number of events 7 • Monthly follow-up with quarterly lab assessments though a median of 1.2 years of follow-up
Adverse events graded by the NIH Division of AIDS grading tables, version 1.0
|
|
Psychiatric disorders
SUICIDE ATTEMPT
|
1.4%
17/1226 • Number of events 17 • Monthly follow-up with quarterly lab assessments though a median of 1.2 years of follow-up
Adverse events graded by the NIH Division of AIDS grading tables, version 1.0
|
1.1%
14/1230 • Number of events 14 • Monthly follow-up with quarterly lab assessments though a median of 1.2 years of follow-up
Adverse events graded by the NIH Division of AIDS grading tables, version 1.0
|
|
Psychiatric disorders
SUICIDAL IDEATION
|
0.41%
5/1226 • Number of events 5 • Monthly follow-up with quarterly lab assessments though a median of 1.2 years of follow-up
Adverse events graded by the NIH Division of AIDS grading tables, version 1.0
|
0.49%
6/1230 • Number of events 6 • Monthly follow-up with quarterly lab assessments though a median of 1.2 years of follow-up
Adverse events graded by the NIH Division of AIDS grading tables, version 1.0
|
|
Blood and lymphatic system disorders
ALT INCREASE
|
0.08%
1/1226 • Number of events 1 • Monthly follow-up with quarterly lab assessments though a median of 1.2 years of follow-up
Adverse events graded by the NIH Division of AIDS grading tables, version 1.0
|
0.33%
4/1230 • Number of events 4 • Monthly follow-up with quarterly lab assessments though a median of 1.2 years of follow-up
Adverse events graded by the NIH Division of AIDS grading tables, version 1.0
|
|
Blood and lymphatic system disorders
AST
|
0.33%
4/1226 • Number of events 4 • Monthly follow-up with quarterly lab assessments though a median of 1.2 years of follow-up
Adverse events graded by the NIH Division of AIDS grading tables, version 1.0
|
0.41%
5/1230 • Number of events 5 • Monthly follow-up with quarterly lab assessments though a median of 1.2 years of follow-up
Adverse events graded by the NIH Division of AIDS grading tables, version 1.0
|
|
Hepatobiliary disorders
APPENDICITIS
|
0.24%
3/1226 • Number of events 3 • Monthly follow-up with quarterly lab assessments though a median of 1.2 years of follow-up
Adverse events graded by the NIH Division of AIDS grading tables, version 1.0
|
0.24%
3/1230 • Number of events 3 • Monthly follow-up with quarterly lab assessments though a median of 1.2 years of follow-up
Adverse events graded by the NIH Division of AIDS grading tables, version 1.0
|
|
Psychiatric disorders
DEPRESSION
|
0.57%
7/1226 • Number of events 7 • Monthly follow-up with quarterly lab assessments though a median of 1.2 years of follow-up
Adverse events graded by the NIH Division of AIDS grading tables, version 1.0
|
0.89%
11/1230 • Number of events 11 • Monthly follow-up with quarterly lab assessments though a median of 1.2 years of follow-up
Adverse events graded by the NIH Division of AIDS grading tables, version 1.0
|
|
Psychiatric disorders
SUICIDAL DEPRESSION
|
0.41%
5/1226 • Number of events 5 • Monthly follow-up with quarterly lab assessments though a median of 1.2 years of follow-up
Adverse events graded by the NIH Division of AIDS grading tables, version 1.0
|
0.49%
6/1230 • Number of events 6 • Monthly follow-up with quarterly lab assessments though a median of 1.2 years of follow-up
Adverse events graded by the NIH Division of AIDS grading tables, version 1.0
|
|
Psychiatric disorders
MAJOR DEPRESSION
|
0.41%
5/1226 • Number of events 5 • Monthly follow-up with quarterly lab assessments though a median of 1.2 years of follow-up
Adverse events graded by the NIH Division of AIDS grading tables, version 1.0
|
0.00%
0/1230 • Monthly follow-up with quarterly lab assessments though a median of 1.2 years of follow-up
Adverse events graded by the NIH Division of AIDS grading tables, version 1.0
|
|
General disorders
OTHER EVENTS
|
2.3%
28/1226 • Number of events 28 • Monthly follow-up with quarterly lab assessments though a median of 1.2 years of follow-up
Adverse events graded by the NIH Division of AIDS grading tables, version 1.0
|
2.4%
29/1230 • Number of events 29 • Monthly follow-up with quarterly lab assessments though a median of 1.2 years of follow-up
Adverse events graded by the NIH Division of AIDS grading tables, version 1.0
|
Other adverse events
| Measure |
TDF/FTC
n=1226 participants at risk
Daily oral emtricitabine/tenofovir disoproxil fumarate
Emtricitabine/tenofovir disoproxil fumarate: Fixed-dose coformulation of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate
|
Placebo
n=1230 participants at risk
Daily oral placebo
Placebo: Placebo for emtricitabine/tenofovir disoproxil fumarate
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
PHARYNGITIS
|
20.2%
248/1226 • Number of events 248 • Monthly follow-up with quarterly lab assessments though a median of 1.2 years of follow-up
Adverse events graded by the NIH Division of AIDS grading tables, version 1.0
|
22.9%
282/1230 • Number of events 282 • Monthly follow-up with quarterly lab assessments though a median of 1.2 years of follow-up
Adverse events graded by the NIH Division of AIDS grading tables, version 1.0
|
|
Gastrointestinal disorders
PARASITIC INFECTION INTESTINAL
|
18.8%
231/1226 • Number of events 231 • Monthly follow-up with quarterly lab assessments though a median of 1.2 years of follow-up
Adverse events graded by the NIH Division of AIDS grading tables, version 1.0
|
17.6%
216/1230 • Number of events 216 • Monthly follow-up with quarterly lab assessments though a median of 1.2 years of follow-up
Adverse events graded by the NIH Division of AIDS grading tables, version 1.0
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
12.3%
151/1226 • Number of events 151 • Monthly follow-up with quarterly lab assessments though a median of 1.2 years of follow-up
Adverse events graded by the NIH Division of AIDS grading tables, version 1.0
|
12.6%
155/1230 • Number of events 155 • Monthly follow-up with quarterly lab assessments though a median of 1.2 years of follow-up
Adverse events graded by the NIH Division of AIDS grading tables, version 1.0
|
|
Investigations
BILIRUBIN INCREASE
|
10.4%
127/1226 • Number of events 127 • Monthly follow-up with quarterly lab assessments though a median of 1.2 years of follow-up
Adverse events graded by the NIH Division of AIDS grading tables, version 1.0
|
10.7%
132/1230 • Number of events 132 • Monthly follow-up with quarterly lab assessments though a median of 1.2 years of follow-up
Adverse events graded by the NIH Division of AIDS grading tables, version 1.0
|
|
Gastrointestinal disorders
DIARRHOEA
|
8.9%
109/1226 • Number of events 109 • Monthly follow-up with quarterly lab assessments though a median of 1.2 years of follow-up
Adverse events graded by the NIH Division of AIDS grading tables, version 1.0
|
10.0%
123/1230 • Number of events 123 • Monthly follow-up with quarterly lab assessments though a median of 1.2 years of follow-up
Adverse events graded by the NIH Division of AIDS grading tables, version 1.0
|
|
Investigations
BLOOD GLUCOSE INCREASED
|
8.9%
109/1226 • Number of events 109 • Monthly follow-up with quarterly lab assessments though a median of 1.2 years of follow-up
Adverse events graded by the NIH Division of AIDS grading tables, version 1.0
|
10.0%
123/1230 • Number of events 123 • Monthly follow-up with quarterly lab assessments though a median of 1.2 years of follow-up
Adverse events graded by the NIH Division of AIDS grading tables, version 1.0
|
|
Investigations
BLOOD PHOSPHORUS DECREASED
|
10.0%
122/1226 • Number of events 122 • Monthly follow-up with quarterly lab assessments though a median of 1.2 years of follow-up
Adverse events graded by the NIH Division of AIDS grading tables, version 1.0
|
8.1%
100/1230 • Number of events 100 • Monthly follow-up with quarterly lab assessments though a median of 1.2 years of follow-up
Adverse events graded by the NIH Division of AIDS grading tables, version 1.0
|
|
Nervous system disorders
HEADACHE
|
8.3%
102/1226 • Number of events 102 • Monthly follow-up with quarterly lab assessments though a median of 1.2 years of follow-up
Adverse events graded by the NIH Division of AIDS grading tables, version 1.0
|
8.7%
107/1230 • Number of events 107 • Monthly follow-up with quarterly lab assessments though a median of 1.2 years of follow-up
Adverse events graded by the NIH Division of AIDS grading tables, version 1.0
|
|
Respiratory, thoracic and mediastinal disorders
NASOPHARYNGITIS
|
8.0%
98/1226 • Number of events 98 • Monthly follow-up with quarterly lab assessments though a median of 1.2 years of follow-up
Adverse events graded by the NIH Division of AIDS grading tables, version 1.0
|
7.5%
92/1230 • Number of events 92 • Monthly follow-up with quarterly lab assessments though a median of 1.2 years of follow-up
Adverse events graded by the NIH Division of AIDS grading tables, version 1.0
|
|
Renal and urinary disorders
URETHRITIS
|
6.9%
84/1226 • Number of events 84 • Monthly follow-up with quarterly lab assessments though a median of 1.2 years of follow-up
Adverse events graded by the NIH Division of AIDS grading tables, version 1.0
|
8.3%
102/1230 • Number of events 102 • Monthly follow-up with quarterly lab assessments though a median of 1.2 years of follow-up
Adverse events graded by the NIH Division of AIDS grading tables, version 1.0
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
6.9%
84/1226 • Number of events 84 • Monthly follow-up with quarterly lab assessments though a median of 1.2 years of follow-up
Adverse events graded by the NIH Division of AIDS grading tables, version 1.0
|
7.1%
87/1230 • Number of events 87 • Monthly follow-up with quarterly lab assessments though a median of 1.2 years of follow-up
Adverse events graded by the NIH Division of AIDS grading tables, version 1.0
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
6.2%
76/1226 • Number of events 76 • Monthly follow-up with quarterly lab assessments though a median of 1.2 years of follow-up
Adverse events graded by the NIH Division of AIDS grading tables, version 1.0
|
7.6%
93/1230 • Number of events 93 • Monthly follow-up with quarterly lab assessments though a median of 1.2 years of follow-up
Adverse events graded by the NIH Division of AIDS grading tables, version 1.0
|
|
Nervous system disorders
DEPRESSION
|
6.6%
81/1226 • Number of events 81 • Monthly follow-up with quarterly lab assessments though a median of 1.2 years of follow-up
Adverse events graded by the NIH Division of AIDS grading tables, version 1.0
|
6.8%
84/1230 • Number of events 84 • Monthly follow-up with quarterly lab assessments though a median of 1.2 years of follow-up
Adverse events graded by the NIH Division of AIDS grading tables, version 1.0
|
|
Infections and infestations
SYPHILIS
|
6.7%
82/1226 • Number of events 82 • Monthly follow-up with quarterly lab assessments though a median of 1.2 years of follow-up
Adverse events graded by the NIH Division of AIDS grading tables, version 1.0
|
5.8%
71/1230 • Number of events 71 • Monthly follow-up with quarterly lab assessments though a median of 1.2 years of follow-up
Adverse events graded by the NIH Division of AIDS grading tables, version 1.0
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
6.0%
73/1226 • Number of events 73 • Monthly follow-up with quarterly lab assessments though a median of 1.2 years of follow-up
Adverse events graded by the NIH Division of AIDS grading tables, version 1.0
|
6.2%
76/1230 • Number of events 76 • Monthly follow-up with quarterly lab assessments though a median of 1.2 years of follow-up
Adverse events graded by the NIH Division of AIDS grading tables, version 1.0
|
|
Infections and infestations
SECONDARY SYPHILIS
|
6.6%
81/1226 • Number of events 81 • Monthly follow-up with quarterly lab assessments though a median of 1.2 years of follow-up
Adverse events graded by the NIH Division of AIDS grading tables, version 1.0
|
5.2%
64/1230 • Number of events 64 • Monthly follow-up with quarterly lab assessments though a median of 1.2 years of follow-up
Adverse events graded by the NIH Division of AIDS grading tables, version 1.0
|
|
Infections and infestations
BLOOD AMYLASE INCREASED
|
5.1%
62/1226 • Number of events 62 • Monthly follow-up with quarterly lab assessments though a median of 1.2 years of follow-up
Adverse events graded by the NIH Division of AIDS grading tables, version 1.0
|
4.6%
57/1230 • Number of events 57 • Monthly follow-up with quarterly lab assessments though a median of 1.2 years of follow-up
Adverse events graded by the NIH Division of AIDS grading tables, version 1.0
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place