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Active, Not Recruiting

NCT Number: 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

The primary objective of this study is to assess the rates of HIV-1 infection in Men (MSM) and transgender women (TGW) who have sex with men and who are administered daily emtricitabine/tenofovir alafenamide (F/TAF) or emtricitabine/tenofovir disoproxil fumarate (F/TDF) with a minimum follow-up of 48 weeks and at least 50% of participants have 96 weeks of follow-up after randomization.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Pre-Exposure Prophylaxis of HIV-1 Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Graz, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Must be at high risk of sexual acquisition of HIV
  • HIV-1 negative status
  • MSM and TGW (male at birth) who have at least one of the following:
  • condomless anal intercourse with at least two unique male partners in the past 12 weeks (partners must be either HIV-infected or of unknown HIV status)
  • documented history of syphilis in the past 24 weeks
  • documented history of rectal gonorrhea or chlamydia in the past 24 weeks
  • Adequate renal function: estimated glomerular filtration rate ≥ 60 mL/min according to the Cockcroft-Gault formula
  • Adequate liver and hematologic function:
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN) and total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
  • Absolute neutrophil count ≥ 1000/mm^3; platelets ≥ 75,000/mm^3; hemoglobin ≥ 10 g/dL

Key Exclusion Criteria

  • Grade 3 or Grade 4 proteinuria or glycosuria that is unexplained or not clinically manageable.

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Treatment and study plan

F/TAF

Drug

200/25 mg tablet administered orally once daily

Other names: Descovy®

F/TDF

Drug

200/300 mg tablet administered orally once daily

Other names: Truvada®

F/TAF Placebo

Drug

Tablet administered orally once daily

F/TDF Placebo

Drug

Tablet administered orally once daily

Primary outcomes

  1. Incidence of HIV-1 Infection Per 100 Person Years (PY)

    Time frame: 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 outcomes

  1. Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48 in the Blinded Phase

    Time frame: Baseline, Week 48

    Percent Change = Change from baseline at Week 48 visit/value at baseline * 100%.

  2. Percent Change From Baseline in Spine BMD at Week 48 in the Blinded Phase

    Time frame: Baseline, Week 48

    Percent Change = Change from baseline at Week 48 visit/value at baseline * 100%.

  3. Percent Change From Baseline in Urine Beta-2-Microglobulin to Creatinine Ratio at Week 48 in the Blinded Phase

    Time frame: 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.

  4. Percent Change From Baseline in Urine Retinol Binding Protein (RBP) to Creatinine Ratio at Week 48 in the Blinded Phase

    Time frame: 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.

  5. Number of Participants by Urine Protein (UP) and Urine Protein to Creatinine Ratio (UPCR) Categories at Week 48 in the Blinded Phase

    Time frame: 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.

  6. Change From Baseline in Serum Creatinine at Week 48 in the Blinded Phase

    Time frame: Baseline, Week 48

  7. Incidence of HIV-1 Infection Per 100 PY

    Time frame: 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)

  8. Percent Change From Baseline in Hip BMD at Week 96 in the Blinded Phase

    Time frame: Baseline, Week 96

    Percent Change = Change from baseline at Week 96 visit/value at baseline * 100%.

  9. Percent Change From Baseline in Spine BMD at Week 96 in the Blinded Phase

    Time frame: Baseline, Week 96

    Percent Change = Change from baseline at Week 96 visit/value at baseline * 100%.

  10. Percent Change From Baseline in Urine Beta-2-Microglobulin to Creatinine Ratio at Week 96 in the Blinded Phase

    Time frame: Baseline, Week 96

    Percent Change = Change from baseline at Week 96 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.

  11. Percent Change From Baseline in Urine RBP to Creatinine Ratio at Week 96 in the Blinded Phase

    Time frame: Baseline, Week 96

    Percent Change = Change from baseline at Week 96 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.

  12. Number of Participants by UP and UPCR Categories at Week 96 in the Blinded Phase

    Time frame: Baseline, Week 96

    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.

  13. Change From Baseline in Serum Creatinine at Week 96 in the Blinded Phase

    Time frame: Baseline, Week 96

  14. Percentage of Participants Experiencing Treatment-Emergent Adverse Events

    Time frame: First dose date up to the data cut for end of blinded treatment (maximum: 157 weeks)

  15. Percentage of Participants Experiencing Any Treatment-Emergent Laboratory Abnormality

    Time frame: First dose date up to the data cut for end of blinded treatment (maximum: 157 weeks)

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study title

A Phase 3, Randomized, Double-blind 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

Acronym: DISCOVER

Important dates

Study start
2016
Primary completion
2019
Study completion
2026
First posted
Jul 22, 2016
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.