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GS-US-200-4334: 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

Study category: Infectious Diseases

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Description

This study will test an experimental drug named GS-6207 (long acting capsid inhibitor) in combination with other HIV medications for the treatment of human immunodeficiency virus (HIV) infection. An experimental drug means that it is not yet approved for the treatment of HIV-1 Infection by the United States Food and Drug Administration (FDA) and your country’s regulatory agency. Other HIV medications included in this study are B/F/TAF (Biktarvy?) and, F/TAF (Descovy?), which are currently approved by the U.S. FDA for the treatment of HIV infection and TAF (VEMLIDY?) and Bictegravir (BIC) which are part of the medication Biktarvy but are not currently approved as a single agent HIV medication by the U.S. FDA. This is a randomized, open label study. Open-label means you and your study doctor will know what study drugs you will be taking. Randomized means the study treatment you take will be chosen by chance (like flipping a coin) to receive one of four study treatments. The randomization for this study is in a 2:2:2:1 ratio. You will have 6 out of 7 chances to receive GS-6207 in combination with other HIV medications and a 1 out of 7 chance to receive B/F/TAF.

Details
Age

Adult

Eligibility

- Age &#8805; 18 years of age at Screening - Plasma HIV-1 RNA &#8805; 200 copies/mL at Screening - CD4+ cell count &#8805; 200 cells/uL at Screening - 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.

Phase

II - Research Studies that gather preliminary data on whether a drug works in people who have a certain condition/disease (that is, the drug's effectiveness). For example, participants receiving the drug may be compared to similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied.

Type of Study

Treatment

Location

University of Colorado Hospital

Principal Investigator
Thomas Campbell

Thomas Campbell

Study ID

Protocol Number: 19-2810

ClinicalTrials.gov: NCT04143594

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