Trial · NCT02842086
Study to Evaluate the Safety and Efficacy of Emtricitabine and Tenofovir Alafenamide (F/TAF) Fixed-Dose Combination Once Daily for Pre-Exposure Prophylaxis in Men and Transgender Women Who Have Sex With Men and Are At Risk of HIV-1 Infection
NCT02842086, Phase 3, Terminated, Gilead Sciences; results first posted 2020-03-17
3 sourcestrials-2026-11-12-0.4.0
Download JSON
Cite this record
ConductScience Library. Study to Evaluate the Safety and Efficacy of Emtricitabine and Tenofovir Alafenamide (F/TAF) Fixed-Dose Combination Once Daily for Pre-Exposure Prophylaxis in Men and Transgender Women Who Have Sex With Men and Are At Risk of HIV-1 Infection. Trials, record NCT02842086. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02842086
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Study to Evaluate the Safety and Efficacy of Emtricitabine and Tenofovir Alafenamide (F/TAF) Fixed-Dose Combination Once Daily for Pre-Exposure Prophylaxis in Men and Transgender Women Who Have Sex With Men and Are At Risk of HIV-1 Infection
- NCT number
- NCT02842086
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 5,399 participants, actual
- Lead sponsor
- Gilead Sciences
- Conditions
- Pre-Exposure Prophylaxis of HIV-1 Infection
- Interventions
- F/TAF, F/TDF, F/TAF Placebo, F/TDF Placebo
- First posted
- 2016-07-22
- Last updated
- 2026-09-08
- Other registries' IDs
- eudract:2016-001399-31
- Results first posted
- 2020-03-17
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of HIV-1 Infection Per 100 Person Years (PY) | When all participants completed minimum follow-up of 48 weeks and at least 50% of the participants completed 96 weeks of follow-up after randomization or permanently discontinued from the study (maximum 125 weeks) | The incidence of HIV-1 infection rate per 100 PY was calculated as the number of participants who became HIV infected during the study after the first dose of study drug divided by the sum of all participants' years (where a year is 365.25 days) of follow-up while at risk of HIV infection during the study. HIV-1 infection is defined by one or more of the following criteria of contributing HIV tests performed via central lab or local lab: * Serologic evidence of seroconversion (reactive screening HIV Antigen/Antibody or Antibody test, confirmed by reactive HIV-1/HIV-2 differentiation assay), excluding HIV vaccinated participants, or * Virologic evidence of HIV-1 infection (positive qualitative HIV-1 RNA test or any detectable quantitative HIV-1 RNA test), or * Evidence of acute HIV-1 infection (reactive p24 Antigen or positive qualitative or quantitative RNA, in the absence of reactive HIV-1 Antibody results) |
| Secondary | Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48 in the Blinded Phase | Baseline, Week 48 | Percent Change = Change from baseline at Week 48 visit/value at baseline \* 100%. |
| Secondary | Percent Change From Baseline in Spine BMD at Week 48 in the Blinded Phase | Baseline, Week 48 | Percent Change = Change from baseline at Week 48 visit/value at baseline \* 100%. |
| Secondary | Percent Change From Baseline in Urine Beta-2-Microglobulin to Creatinine Ratio at Week 48 in the Blinded Phase | Baseline, Week 48 | Percent Change = Change from baseline at Week 48 visit/value at baseline \* 100%. For urine creatinine, value of \< 1 was handled as a missing value in its summary and the calculation of related ratios. |
| Secondary | Percent Change From Baseline in Urine Retinol Binding Protein (RBP) to Creatinine Ratio at Week 48 in the Blinded Phase | Baseline, Week 48 | Percent Change = Change from baseline at Week 48 visit/value at baseline \* 100%. For urine creatinine, value of \< 1 was handled as a missing value in its summary and the calculation of related ratios. |
| Secondary | Number of Participants by Urine Protein (UP) and Urine Protein to Creatinine Ratio (UPCR) Categories at Week 48 in the Blinded Phase | Baseline, Week 48 | The UPCR was only calculated when corresponding UP ≥ 4.0 mg/dL. The UPCR "≤ 200 mg/g" category includes both participants with UP \< 4.0 mg/dL and participants with UPCR ≤ 200 mg/g. |
| Secondary | Change From Baseline in Serum Creatinine at Week 48 in the Blinded Phase | Baseline, Week 48 | |
| Secondary | Incidence of HIV-1 Infection Per 100 PY | When all participants have 96 weeks of follow-up after randomization or permanently discontinued from the study (maximum 157 weeks) | The incidence of HIV-1 infection rate per 100 PY was calculated as the number of participants who became HIV infected during the study after the first dose of study drug divided by the sum of all participants' years (where a year is 365.25 days) of follow-up while at risk of HIV infection during the study. HIV-1 infection is defined by one or more of the following criteria of contributing HIV tests performed via central lab or local lab: * Serologic evidence of seroconversion (reactive screening HIV Antigen/Antibody or Antibody test, confirmed by reactive HIV-1/HIV-2 differentiation assay), excluding HIV vaccinated participants, or * Virologic evidence of HIV-1 infection (positive qualitative HIV-1 RNA test or any detectable quantitative HIV-1 RNA test), or * Evidence of acute HIV-1 infection (reactive p24 Antigen or positive qualitative or quantitative RNA, in the absence of reactive HIV-1 Antibody results) |
| Secondary | Percent Change From Baseline in Hip BMD at Week 96 in the Blinded Phase | Baseline, Week 96 | Percent Change = Change from baseline at Week 96 visit/value at baseline \* 100%. |
| Secondary | Percent Change From Baseline in Spine BMD at Week 96 in the Blinded Phase | Baseline, Week 96 | Percent Change = Change from baseline at Week 96 visit/value at baseline \* 100%. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence of HIV-1 Infection Per 100 Person Years (PY) | When all participants completed minimum follow-up of 48 weeks and at least 50% of the participants completed 96 weeks of follow-up after randomization or permanently discontinued from the study (maximum 125 weeks) | The Full Analysis Set included all participants who were randomized into the study, received at least 1 dose of study drug, were not HIV positive on Day 1, and had at least 1 postbaseline HIV laboratory assessment. | HIV-1 infections per 100 PY | NUMBER |
| SECONDARY | Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48 in the Blinded Phase | Baseline, Week 48 | Hip Dual-Energy X-ray Absorptiometry (DXA) Analysis Set included all DXA substudy participants who were randomized and received at least one dose of study drug, and had nonmissing hip BMD value for the baseline visit. Participants were grouped according to the treatment they actually received. Participants with available data were analyzed. | Percent Change | MEAN |
| SECONDARY | Percent Change From Baseline in Spine BMD at Week 48 in the Blinded Phase | Baseline, Week 48 | Spine DXA Analysis Set included all DXA substudy participants who were randomized and received at least one dose of study drug, and had nonmissing spine BMD value for the baseline visit. Participants were grouped according to the treatment they actually received. Participants with available data were analyzed. | Percent Change | MEAN |
| SECONDARY | Percent Change From Baseline in Urine Beta-2-Microglobulin to Creatinine Ratio at Week 48 in the Blinded Phase | Baseline, Week 48 | The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. Participants were grouped according to the treatment they actually received. Participants with available data were analyzed. | Percent Change | MEDIAN |
| SECONDARY | Percent Change From Baseline in Urine Retinol Binding Protein (RBP) to Creatinine Ratio at Week 48 in the Blinded Phase | Baseline, Week 48 | Participants in Safety Analysis Set with available data were analyzed. | Percent Change | MEDIAN |
| SECONDARY | Number of Participants by Urine Protein (UP) and Urine Protein to Creatinine Ratio (UPCR) Categories at Week 48 in the Blinded Phase | Baseline, Week 48 | Participants in Safety Analysis Set with available data were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Serum Creatinine at Week 48 in the Blinded Phase | Baseline, Week 48 | Participants in Safety Analysis Set with available data were analyzed. | mg/dL | MEAN |
| SECONDARY | Incidence of HIV-1 Infection Per 100 PY | When all participants have 96 weeks of follow-up after randomization or permanently discontinued from the study (maximum 157 weeks) | Participants in Full Analysis Set were analyzed. | HIV-1 infections per 100 PY | NUMBER |
| SECONDARY | Percent Change From Baseline in Hip BMD at Week 96 in the Blinded Phase | Baseline, Week 96 | Participants in Hip DXA Analysis Set with available data were analyzed. | Percent Change | MEAN |
| SECONDARY | Percent Change From Baseline in Spine BMD at Week 96 in the Blinded Phase | Baseline, Week 96 | Participants in Spine DXA Analysis Set with available data were analyzed. | Percent Change | MEAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group44
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence of HIV-1 Infection Per 100 Person Years (PY) | Descovy (DVY) | 0.160 | 95% Confidence Interval 0.064 to 0.330 | HIV-1 infections per 100 PY | |
| Incidence of HIV-1 Infection Per 100 Person Years (PY) | Truvada (TVD) | 0.342 | 95% Confidence Interval 0.191 to 0.564 | HIV-1 infections per 100 PY | |
| Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48 in the Blinded Phase | Descovy (DVY) | 0.218 | Standard Deviation 2.3668 | Percent Change | |
| Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48 in the Blinded Phase | Truvada (TVD) | -0.968 | Standard Deviation 2.4343 | Percent Change | |
| Percent Change From Baseline in Spine BMD at Week 48 in the Blinded Phase | Descovy (DVY) | 0.512 | Standard Deviation 2.9854 | Percent Change | |
| Percent Change From Baseline in Spine BMD at Week 48 in the Blinded Phase | Truvada (TVD) | -1.061 | Standard Deviation 2.9382 | Percent Change | |
| Percent Change From Baseline in Urine Beta-2-Microglobulin to Creatinine Ratio at Week 48 in the Blinded Phase | Descovy (DVY) | -10.6 | Inter-Quartile Range -42.0 to 25.9 | Percent Change | |
| Percent Change From Baseline in Urine Beta-2-Microglobulin to Creatinine Ratio at Week 48 in the Blinded Phase | Truvada (TVD) | 15.4 | Inter-Quartile Range -22.9 to 97.2 | Percent Change | |
| Percent Change From Baseline in Urine Retinol Binding Protein (RBP) to Creatinine Ratio at Week 48 in the Blinded Phase | Descovy (DVY) | 0.1 | Inter-Quartile Range -24.9 to 35.3 | Percent Change | |
| Percent Change From Baseline in Urine Retinol Binding Protein (RBP) to Creatinine Ratio at Week 48 in the Blinded Phase | Truvada (TVD) | 20.0 | Inter-Quartile Range -13.0 to 68.2 | Percent Change |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Descovy (DVY) | 2,700 | |
| Overall Study | STARTED | Truvada (TVD) | 2,699 | |
| Overall Study | COMPLETED | Descovy (DVY) | 2,156 | |
| Overall Study | COMPLETED | Truvada (TVD) | 2,206 | |
| Overall Study | NOT COMPLETED | Descovy (DVY) | 544 | |
| Overall Study | NOT COMPLETED | Truvada (TVD) | 493 |
Source ClinicalTrials.gov
Adverse events624
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Descovy (DVY) | 479 | 2,694 | |
| other | Diarrhoea | Gastrointestinal disorders | Truvada (TVD) | 451 | 2,693 | |
| other | Nausea | Gastrointestinal disorders | Descovy (DVY) | 209 | 2,694 | |
| other | Nausea | Gastrointestinal disorders | Truvada (TVD) | 204 | 2,693 | |
| other | Fatigue | General disorders | Descovy (DVY) | 180 | 2,694 | |
| other | Fatigue | General disorders | Truvada (TVD) | 181 | 2,693 | |
| other | Anal chlamydia infection | Infections and infestations | Descovy (DVY) | 890 | 2,694 | |
| other | Anal chlamydia infection | Infections and infestations | Truvada (TVD) | 902 | 2,693 | |
| other | Gastroenteritis | Infections and infestations | Descovy (DVY) | 171 | 2,694 | |
| other | Gastroenteritis | Infections and infestations | Truvada (TVD) | 141 | 2,693 |
1 to 10 of 624Source ClinicalTrials.gov
See all 624 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Descovy (DVY) | 3 | 2,694 |
| Total, all-cause mortality | Truvada (TVD) | 3 | 2,693 |
| Total, other adverse events | Descovy (DVY) | 2,258 | 2,694 |
| Total, other adverse events | Truvada (TVD) | 2,229 | 2,693 |
| Total, serious adverse events | Descovy (DVY) | 202 | 2,694 |
| Total, serious adverse events | Truvada (TVD) | 186 | 2,693 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Descovy (DVY) vs Truvada (TVD): deaths from any cause | Trial comparisons |
| Descovy (DVY) vs Truvada (TVD): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02842086
GET https://conductscience.org/api/trials/v1/NCT02842086/results?page=2