Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Sacramento, California and other locations
Dates
study started
estimated completion

Description

Summary

The primary objective of this study is to evaluate the efficacy of lenacapavir (formerly GS-6207) containing regimens in people living with HIV (PLWH).

Official Title

A Phase 2 Randomized, Open Label, Active Controlled Study Evaluating the Safety and Efficacy of Long-acting Capsid Inhibitor GS-6207 in Combination With Other Antiretroviral Agents in People Living With HIV

Keywords

HIV-1-infection Oral Lenacapavir F/TAF Subcutaneous Lenacapavir TAF BIC B/F/TAF Lenacapavir, F/TAF, and TAF Lenacapavir, F/TAF, and BIC Lenacapavir and F/TAF

Eligibility

You can join if…

Open to people ages 18 years and up

  • Antiretroviral (ARV) naive with no use of any ARV within one month of screening. Use of pre-exposure prophylaxis (PrEP) (any duration), post-exposure prophylaxis (PEP) (any duration), or HIV-1 treatment (< 10 days therapy total) > 1 month prior to screening is permitted
  • HIV-1 RNA ≥ 200 copies/mL at screening
  • CD4+ cell count ≥ 200 cells/microliter at screening

You CAN'T join if...

  • Current Hepatitis B Virus (HBV) or Hepatitis C virus (HCV) infection

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

Locations

  • One Community Health accepting new patients
    Sacramento California 95811 United States
  • Mills Clinical Research at Men's Health Foundation accepting new patients
    Los Angeles California 90069 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Gilead Sciences
Links
Sign up for this study
ID
NCT04143594
Phase
Phase 2
Study Type
Interventional
Last Updated