Study to Evaluate drug GS-8588 in People With HIV-1 Who are Virologically Suppressed on Antiretroviral Therapy
Administratively Closed
18 years - 99 years
All
Phase
1
7 participants needed
1 Location
Brief description of study
The research study is being conducted to test an experimental drug, GS-8588, for the treatment and remission of human immunodeficiency virus (HIV) infection.
GS-8588 is a special type of protein, called an antibody, that helps the immune system bring your immune cells closer to the cells infected with HIV. Finding ways to target and destroy the hidden HIV in body cells is a major challenge facing HIV researchers who are exploring different strategies to find a potential cure for HIV.
Detailed description of study
Participants enrolled in the single dose cohorts will be asked to complete the following research procedures:
• Complete initial screening visit; includes consent process, labs, EKG, physical exam and questions answered by study doctor (approximately 2 hours)
• Be randomized (such as with the flip of a coin) to one of the study groups
• Receive either a placebo or the study drug, GS-8588; requires 2-hour infusion
• Have at least 1 overnight stay of 5 consecutive days/4 nights
• Be asked to attend at least 9 study visits over the course of about 3 months
• Have approximately 21 blood draws and approximately 8 urine samples taken
***Future cohorts requiring multiple doses will require additional overnight stays and study visits. Time commitment will be approximately 5 months.
Compensation:
•Participants will be monetarily compensated for their time
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: HIV
-
Age: 18 years - 99 years
-
Gender: All
Major criteria includes, but not limited to:
• Age ≥ 18 years at screening
• Able to understand and sign a written informed consent, which must be signed before study enrollment
• On stable ART treatment for at least 6 consecutive months prior to screening, throughout the duration of study treatment and follow-up (Entry inhibitors, such as, maraviroc, enfuvirtide, ibalizumab, or fostemsavir, are not allowed as part of current ART regimen)
• Undetectable (Plasma HIV-1 RNA < 50 copies/mL at screening)
• At least two consecutive documented undetectable levels more than 6 months prior to screening visit
Updated on
05 Dec 2024.
Study ID: 851292
