A Phase 2/3 Study to Evaluate the Safety and Efficacy of Long Acting Capsid Inhibitor GS-6207 in Combination with an Optimized Background Regimen in Heavily Treatment Experienced People Living with HIV-1 Infection with Multidrug Resistance

Recruitment & Eligibility

Status: completed

Sex: All

Target Recruitment: 100

Inclusion Criteria

Are receiving a stable failing regimen for > 8 weeks before Screening and are willing to continue that regimen until Day 1. Cohort 1 participants should be willing to continue their failing regimen until Day 14
-Have HIV 1 RNA >= 400 copies/mL at Screening
-Have resistance to >= 2 antiretroviral medications from each of >= 3 of the 4 main classes of antiretroviral medications (NRTI, NNRTI, PI, INSTI). Resistance to FTC or 3TC associated with the presence of the M184V/I RT mutation cannot be used for the purpose of determining eligibility for this criterion
-Have =< 2 fully active ARV remaining from the 4 main classes that can be effectively combined to form a viable regimen in the opinion of the investigator based on resistance, tolerability, contraindication, safety, drug access, or acceptability to the participant
-Able and willing to receive an optimized background regimen together with GS-6207

Exclusion Criteria

-Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days before screening
-Untreated or newly treated (< 3 months prior to screening) Hepatitis B Virus (HBV) infection. Participants may be enrolled regardless of the HBV serology criteria below if they are receiving treatment with anti-HBV activity and plan to continue the treatment during the study. Hepatitis B infection is defined as screening results showing either or both of:
a. Positive HBV surface antigen
b. Positive HBV core antibody and negative HBV surface antibody. Participants may be enrolled with these findings if they have HBV DNA -Hepatitis C virus (HCV) antibody positive and HCV RNA > LLOQ
-A history of or current clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, or variceal bleeding)
-Treatment within three months prior to screening, or anticipated treatment during the study period with immunosuppressant therapies, hydroxyurea, foscarnet, radiation, or cytotoxic chemotherapeutic agents without prior approval from Sponsor prior to randomization.
-Active malignancy requiring acute therapy (with the exception of local cutaneous Kaposi's sarcoma)
-Current alcohol or substance use judged by the Investigator to potentially interfere with the participant's study compliance
-Participation or planned participation in any other clinical trial (including observational trials) without prior approval from the sponsor throughout the study

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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