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Trial record 1 of 1 for:    02842086
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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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pre-Exposure Prophylaxis of HIV-1 Infection Drug: F/TAF Drug: F/TDF Drug: F/TAF Placebo Drug: F/TDF Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : September 2, 2016
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: F/TAF
F/TAF+ F/TDF placebo for at least 96 weeks
Drug: F/TAF
200/25 mg tablet administered orally once daily
Other Name: Descovy®

Drug: F/TDF Placebo
Tablet administered orally once daily

Experimental: F/TDF
F/TDF+ F/TAF placebo for at least 96 weeks
Drug: F/TDF
200/300 mg tablet administered orally once daily
Other Name: Truvada®

Drug: F/TAF Placebo
Tablet administered orally once daily

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.
Drug: F/TAF
200/25 mg tablet administered orally once daily
Other Name: Descovy®




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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 ]
  2. Percent Change From Baseline in Spine BMD at Week 48 in the Blinded Phase in a Subset of Participants [ Time Frame: Baseline; Week 48 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. Change From Baseline in Serum Creatinine at Week 48 in the Blinded Phase [ Time Frame: Baseline; Week 48 ]
  7. Percent Change from Baseline in Hip BMD at Week 96 in the Blinded Phase in a Subset of Participants [ Time Frame: Baseline; Week 96 ]
  8. Percent Change from Baseline in Spine BMD at Week 96 in the Blinded Phase in a Subset of Participants [ Time Frame: Baseline; Week 96 ]
  9. 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 ]
  10. 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 ]
  11. Assessment of Renal Biomarkers at Week 96 in the Blinded Phase: Distribution of UP and UPCR categories [ Time Frame: Week 96 ]
  12. Change From Baseline in Serum Creatinine at Week 96 in the Blinded Phase [ Time Frame: Week 96 ]
  13. Incidence of Treatment-Emergent Adverse Events [ Time Frame: At least 144 weeks plus 30 days ]
  14. Incidence of Treatment-Emergent Laboratory Toxicities [ Time Frame: At least 144 weeks plus 30 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Men and Transgender Women
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02842086


  Show 93 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Gilead Study Director Gilead Sciences

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02842086     History of Changes
Other Study ID Numbers: GS-US-412-2055
2016-001399-31 ( EudraCT Number )
First Posted: July 22, 2016    Key Record Dates
Last Update Posted: June 1, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Tenofovir
Emtricitabine
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents