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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 (DISCOVER)

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ClinicalTrials.gov Identifier: NCT02842086
Recruitment Status : Active, not recruiting
First Posted : July 22, 2016
Last Update Posted : June 1, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

July 20, 2016
July 22, 2016
June 1, 2018
September 2, 2016
May 2019   (Final data collection date for primary outcome measure)
Incidence of HIV-1 infection per 100 Person Years (PY) [ Time Frame: When all participants have at least 96 weeks of follow-up after randomization. ]

HIV-1 infection is defined by one or more of the following criteria of 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)
Incidence of Seroconversions per 100 Person Years (PY) as Defined by the HIV-1 RNA by Polymerase Chain Reaction (PCR) [ Time Frame: When the last participant has a minimum of 48 weeks of follow-up and at least 50% of the participants have at least 96 weeks of follow-up after randomization ]
Complete list of historical versions of study NCT02842086 on ClinicalTrials.gov Archive Site
  • Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48 in the Blinded Phase in a Subset of Participants [ Time Frame: Baseline; Week 48 ]
  • Percent Change From Baseline in Spine BMD at Week 48 in the Blinded Phase in a Subset of Participants [ Time Frame: Baseline; Week 48 ]
  • Assessment of Renal Biomarkers at Week 48 in the Blinded Phase: Percent Change from Baseline in Urine Beta-2-Microglobulin to Creatinine Ratio [ Time Frame: Baseline; Week 48 ]
  • Assessment of Renal Biomarkers at Week 48 in the Blinded phase: Percent Change from Baseline in Urine RBP to Creatinine Ratio [ Time Frame: Baseline; Week 48 ]
  • Assessment of Renal Biomarkers at Week 48 in the Blinded Phase: Distribution of UP and Urine Protein to Creatinine Ratio (UPCR) Categories [ Time Frame: Baseline; Week 48 ]
  • Change From Baseline in Serum Creatinine at Week 48 in the Blinded Phase [ Time Frame: Baseline; Week 48 ]
  • Percent Change from Baseline in Hip BMD at Week 96 in the Blinded Phase in a Subset of Participants [ Time Frame: Baseline; Week 96 ]
  • Percent Change from Baseline in Spine BMD at Week 96 in the Blinded Phase in a Subset of Participants [ Time Frame: Baseline; Week 96 ]
  • Assessment of Renal Biomarkers at Week 96 in the Blinded Phase: Percent Change From Baseline in Urine Beta-2-Microglobulin to Creatinine Ratio [ Time Frame: Baseline; Week 96 ]
  • Assessment of Renal Biomarkers at Week 96 in the Blinded Phase: Percent Change From Baseline in Urine RBP to Creatinine Ratio [ Time Frame: Week 96 ]
  • Assessment of Renal Biomarkers at Week 96 in the Blinded Phase: Distribution of UP and UPCR categories [ Time Frame: Week 96 ]
  • Change From Baseline in Serum Creatinine at Week 96 in the Blinded Phase [ Time Frame: Week 96 ]
  • Incidence of Treatment-Emergent Adverse Events [ Time Frame: At least 144 weeks plus 30 days ]
  • Incidence of Treatment-Emergent Laboratory Toxicities [ Time Frame: At least 144 weeks plus 30 days ]
  • Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48 in the Blinded Phase in a Subset of Participants [ Time Frame: Baseline; Week 48 ]
  • Percent Change From Baseline in Spine BMD at Week 48 in the Blinded Phase in a Subset of Participants [ Time Frame: Baseline; Week 48 ]
  • Percent Change From Baseline in Renal Biomarkers of Urine Retinol-Binding Protein (RBP) to Creatinine Ratio at Week 48 in the Blinded Phase [ Time Frame: Baseline; Week 48 ]
  • Percent Change From Baseline in Renal Biomarkers of Beta-2-Microglobulin to Creatinine Ratio at Week 48 in the Blinded Phase [ Time Frame: Baseline; Week 48 ]
  • Percent Change From Baseline in Renal Biomarkers of Urine Protein-to-Creatinine Ratio (UPCR) at Week 48 in the Blinded Phase [ Time Frame: Baseline; Week 48 ]
  • Change From Baseline in Serum Creatinine at Week 48 in the Blinded Phase [ Time Frame: Baseline; Week 48 ]
  • Incidence of Seroconversions per 100 PY as Defined by the HIV RNA-1 by PCR at the end of the Blinded Phase [ Time Frame: At least 96 weeks ]
  • Percent Change from Baseline in Hip BMD at Week 96 in the Blinded Phase in a Subset of Participants [ Time Frame: Baseline; Week 96 ]
  • Percent Change from Baseline in Spine BMD at Week 96 in the Blinded Phase in a Subset of Participants [ Time Frame: Baseline; Week 96 ]
  • Percent Change From Baseline in Renal Biomarkers of Urine RBP to Creatinine Ratio at Week 96 in the Blinded Phase [ Time Frame: Baseline; Week 96 ]
  • Percent Change From Baseline in Renal Biomarkers of Urine Beta-2-Microglobulin to Creatinine Ratio at Week 96 in the Blinded Phase [ Time Frame: Week 96 ]
  • Percent Change From Baseline in Renal Biomarkers of Urine Protein-to-Creatinine Ratio (UPCR) at Week 96 in the Blinded Phase [ Time Frame: Week 96 ]
  • Change From Baseline in Serum Creatinine at Week 96 in the Blinded Phase [ Time Frame: Week 96 ]
  • Incidence of Treatment-Emergent Adverse Events [ Time Frame: At least 144 weeks plus 30 days ]
  • Incidence of Treatment-Emergent Laboratory Toxicities [ Time Frame: At least 144 weeks plus 30 days ]
Not Provided
Not Provided
 
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
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
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 DF (F/TDF) when all participants have reached at least 96 weeks of follow-up after randomization.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Pre-Exposure Prophylaxis of HIV-1 Infection
  • Drug: F/TAF
    200/25 mg tablet administered orally once daily
    Other Name: Descovy®
  • Drug: F/TDF
    200/300 mg tablet administered orally once daily
    Other Name: Truvada®
  • Drug: F/TAF Placebo
    Tablet administered orally once daily
  • Drug: F/TDF Placebo
    Tablet administered orally once daily
  • Experimental: F/TAF
    F/TAF+ F/TDF placebo for at least 96 weeks
    Interventions:
    • Drug: F/TAF
    • Drug: F/TDF Placebo
  • Experimental: F/TDF
    F/TDF+ F/TAF placebo for at least 96 weeks
    Interventions:
    • Drug: F/TDF
    • Drug: F/TAF Placebo
  • Experimental: Open-label Extension
    Once all participants have been on blinded treatment for at least 96 weeks, the study will be unblinded and participants will be offered the option to continue on open-label F/TAF treatment in the open-label extension for 48 weeks.
    Intervention: Drug: F/TAF
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
5400
5000
September 2020
May 2019   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Gender Eligibility Description: Men and Transgender Women
18 Years and older   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Austria,   Canada,   Denmark,   France,   Germany,   Ireland,   Italy,   Netherlands,   Spain,   United Kingdom,   United States
 
 
NCT02842086
GS-US-412-2055
2016-001399-31 ( EudraCT Number )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Gilead Sciences
Gilead Sciences
Not Provided
Study Director: Gilead Study Director Gilead Sciences
Gilead Sciences
May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP