Clinical Trial:

HIV in women

Full Name
HIV in Women (GS-US-236-0128): A randomized, double-blind phase 3B study to evaluate the safety and efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate versus ritonavir-boosted atazanavir plus emtricitabine/tenofovir disoproxil fumarate in HIV-1 infected, antiretroviral treatment-naïve women (2_PRO00000343)

Description

Participants will be randomized to one of two treatment arms—Arm 1: EVG/COBI/FTC/TDF STR active + ritonavir placebo + atazanavir placebo + Truvada® placebo or Arm 2: Ritonavir active + atazanavir active + Truvada® active + EVG/COBI/FTC/TDF STR placebo, in the form of pills to be taken once daily. Participants will return for study visits at Weeks 4, 8, 12, 16, and then every 8 weeks through Week 48. After Week 48, they will continue to take their blinded study drug and attend visits every 12 weeks until treatment assignments have been unblinded. Participants will then return for an Unblinding Visit, and thereafter complete a 30-day follow-up visit or telephone call.

Eligibility

Inclusion Criteria
  • Must be female (at birth) and at least 18 years old
  • Able to understand and sign written consent
  • No prior use of antiretroviral drugs
  • Appropriate blood levels
  • Adequate organ function
  • Cannot be pregnant or breastfeeding
  • If of childbearing potential, must agree to protocol-recommended contraception
  • Cannot be receiving drug treatment for Hepatitis C
Doctor(s) Running This Study

Specialties

  • Infectious Diseases
  • Internal Medicine

Area of focus i

  • Hepatitis Care
  • HIV Care
  • HIV Pre-exposure Prophylaxis (PrEP)
  • LGBTQ+ Patient Support
  • Transgender health

LVPG Cliniciani

Accepting New Patients