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) |
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.
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
sites
Orlando Immunology Center Orlando Immunology Center , or simply (OIC) is a part of Infectious...
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