Safety, Pharmacokinetics, and Antiviral Activity of GS-6207 Administered Subcutaneously in HIV-1 Infected Adults



Status:Recruiting
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 65
Updated:3/6/2019
Start Date:November 26, 2018
End Date:March 2020
Contact:Gilead Clinical Study Information Center
Email:GileadClinicalTrials@gilead.com
Phone:1-833-445-3230 (GILEAD-0)

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A Phase 1b Randomized, Double-Blinded, Placebo Controlled, Multi-Cohort Study of the Safety, Pharmacokinetics, and Antiviral Activity of GS-6207 Administered Subcutaneously in HIV-1 Infected Subjects

The primary objective of this study is to evaluate the short-term antiviral activity of
GS-6207 compared to placebo in HIV-1 infected adults who are antiretroviral treatment naive
or are experienced but capsid inhibitor (CAI) naive.


Key Inclusion Criteria:

- Plasma HIV-1 RNA ≥ 10,000 copies/mL but ≤ 400,000 copies/mL and CD4+ cell count > 200
cells/mm^3

- Treatment naive or experienced but CAI and integrase strand transfer inhibitor (INSTI)
naïve, and have not received any antiretroviral therapy (ART) within 12 weeks of
screening

- Screening genotype report must show sensitivity to B/F/TAF to allow its initiation on
Day 10

- Screening genotype report must show sensitivity to at least one agent in either
non-nucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI)
class to allow its use as part of standard of care oral antiretroviral treatment in
the future

- Have adequate renal function (estimated glomerular filtration rate ≥ 70 mL/min)

- No clinically significant abnormalities in ECG at Screening

- Willing to initiate B/F/TAF on Day 10 after completion of all assessments

Key Exclusion Criteria:

- Pregnant or lactating

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
We found this trial at
12
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Berkley, Michigan 48072
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Fort Pierce, Florida 34982
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5901 West Olympic Boulevard
Los Angeles, California 90036
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Los Angeles, California 90069
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1701 North Mills Avenue
Orlando, Florida 32803
(407)647-3960
Orlando Immunology Center Orlando Immunology Center , or simply (OIC) is a part of Infectious...
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Sacramento, California 95187
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West Palm Beach, Florida 33401
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