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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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by Gilead Sciences
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT02842086
First received: July 20, 2016
Last updated: March 21, 2017
Last verified: March 2017
  Purpose
The primary objective of this study is to assess the rates of HIV-1 seroconversion 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) with a minimum follow-up of 48 weeks and at least 50% of participants have 96 weeks of follow-up.

Condition Intervention 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
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 5000
Actual Study Start Date: September 2, 2016
Estimated Study Completion Date: September 2020
Estimated Primary Completion Date: February 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: F/TAF
200/25 mg tablet administered orally once daily
Other Name: Descovy®

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Men and Transgender Women
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02842086

Contacts
Contact: Gilead Study Team GS-US-412-2055@gilead.com

  Show 98 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Gilead Study Director Gilead Sciences
  More Information

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02842086     History of Changes
Other Study ID Numbers: GS-US-412-2055
2016-001399-31 ( EudraCT Number )
Study First Received: July 20, 2016
Last Updated: March 21, 2017

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
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
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

ClinicalTrials.gov processed this record on March 23, 2017