HIV -1 Infection study: GS-0415
Official title Study of GS-0415 and How It Works in People With HIV
ClinicalTrials.gov ID: NCT07719491
What this study is testing
What is GS-0415?
GS-0415 is an investigational drug being studied as a potential treatment for HIV-1 infection.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to learn how safe and well tolerated GS‑0415 is, and how it moves through the body when given in increasing doses.
- Who it's for
- It is looking for adults with HIV who are already taking antiretroviral therapy and whose virus is under control.
- What's involved
- Participants will receive single and multiple injections either under the skin or into a vein, and will have blood tests and safety checks during the study.
- Time commitment
- The study lasts several weeks, with multiple clinic visits for dosing and monitoring.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Age ≥ 18 years and age ≤ 65 years at screening
- On stable antiretroviral (ARV) treatment for ≥ 12 consecutive months prior to screening, throughout the duration of study treatment and follow-up
- The following ARV agents are not allowed as part of the current ART regimen: entry inhibitors (maraviroc, enfuvirtide, ibalizumab, or fostemsavir)
- Plasma HIV-1 RNA \< 50 copies/mL for ≥ 12 months before and at screening with at least 2 documented HIV-1 RNA \<50 copies/mL within the last 12...
- Clusters of differentiation 4 (CD4) count ≥ 350 cells/μL
You likely can't join if
- Documented history of pre-ART CD4 nadir \< 100 cells/μL. Unknown pre-ART CD4 nadir is acceptable
- Known to have initiated ART within 6 months of HIV infection. Unknown time between infection and ART initiation is acceptable
- Females who are pregnant or breastfeeding or who may wish to become pregnant during the study or within 42 days after last study drug administration
- Positive HBV surface antigen, regardless of HBV core antibody status, at the Screening visit
- Positive HBV core antibody and negative HBV surface antibody, regardless of HBV surface antigen status, at the Screening visit
- Have active hepatitis C virus (HCV) infection: 1.) Positive anti-HCV antibody and negative HCV polymerase chain reaction (PCR) results are acceptable
See the full eligibility criteria
- Age ≥ 18 years and age ≤ 65 years at screening
- On stable antiretroviral (ARV) treatment for ≥ 12 consecutive months prior to screening, throughout the duration of study treatment and follow-up
- The following ARV agents are not allowed as part of the current ART regimen: entry inhibitors (maraviroc, enfuvirtide, ibalizumab, or fostemsavir)
- Plasma HIV-1 RNA \< 50 copies/mL for ≥ 12 months before and at screening with at least 2 documented HIV-1 RNA \<50 copies/mL within the last 12 months.
- Clusters of differentiation 4 (CD4) count ≥ 350 cells/μL
- Weight ≥ 50 kg and ≤ 110 kg at screening and Day 1
- Body mass index (BMI) ≥ 18.5 kg/m2 and ≤ 35 kg/m2 at screening and Day 1 Key
- Documented history of pre-ART CD4 nadir \< 100 cells/μL. Unknown pre-ART CD4 nadir is acceptable
- Known to have initiated ART within 6 months of HIV infection. Unknown time between infection and ART initiation is acceptable
- Females who are pregnant or breastfeeding or who may wish to become pregnant during the study or within 42 days after last study drug administration
- Positive HBV surface antigen, regardless of HBV core antibody status, at the Screening visit
- Positive HBV core antibody and negative HBV surface antibody, regardless of HBV surface antigen status, at the Screening visit
- Have active hepatitis C virus (HCV) infection: 1.) Positive anti-HCV antibody and negative HCV polymerase chain reaction (PCR) results are acceptable
- Have a history of any of the following: 2.) Significant serious skin disease, such as but not limited to rash, food allergy, eczema, psoriasis, or urticaria as assessed by the investigator 3.) Significant drug...
The study team makes the final eligibility decision.
Where it is enrolling
- Los Angeles, California, United States
- Washington D.C., District of Columbia, United States
- Miami Lakes, Florida, United States
- West Palm Beach, Florida, United States
- Atlanta, Georgia, United States
- Columbus, Georgia, United States
- Indianapolis, Indiana, United States
- Boston, Massachusetts, United States
- Las Vegas, Nevada, United States
- The Bronx, New York, United States
- Durham, North Carolina, United States
- Winston-Salem, North Carolina, United States
- Cincinnati, Ohio, United States
- Columbus, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Los Angeles, California, United States; Washington D.C., District of Columbia, United States; Miami Lakes, Florida, United States; West Palm Beach, Florida, United States; Atlanta, Georgia, United States; Columbus, Georgia, United States and 8 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.