GS-0415 for HIV
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new drug, GS-0415, for individuals living with HIV who are already on antiretroviral treatment. The main goal is to assess the safety and tolerability of GS-0415 when administered in varying doses, either as a single dose or multiple doses, and to understand its metabolism in the body. Participants who have undergone HIV treatments for at least a year and maintain a stable, low viral load might be suitable candidates. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Is there any evidence suggesting that GS-0415 is likely to be safe for humans?
Research has shown that GS-0415 remains in the early stages of testing, meaning complete safety information from human studies may not yet be available. However, animal tests have revealed some potential issues. Specifically, high doses of GS-0415 caused liver and heart problems in dogs and rats. While it's important to consider these findings, results from animal studies often differ from human outcomes.
Since GS-0415 is in the early phase of trials, the primary goal is to assess its safety and tolerability in humans. Researchers closely monitor for any side effects or problems as people begin using the drug.
The key point is that although animal studies have noted some safety concerns, the current human trials are designed to carefully evaluate these risks. Participants will be closely monitored to address any issues promptly.12345Why do researchers think this study treatment might be promising for HIV?
Researchers are excited about GS-0415 for HIV because it offers a new way to tackle the virus through subcutaneous or intravenous administration. Unlike standard HIV treatments, which often rely on oral antiretroviral drugs, GS-0415 is administered directly into the body, potentially allowing for more controlled and targeted delivery. This treatment introduces innovative dosing strategies, like single and multiple ascending doses, which might enhance effectiveness and reduce side effects. The unique approach of GS-0415 could represent a significant step forward in HIV treatment, offering hope for better management of the condition.
What evidence suggests that GS-0415 could be an effective treatment for HIV?
Research has shown that GS-0415, a new drug, is being tested to treat HIV. In this trial, participants will receive varying doses of GS-0415 to evaluate its effectiveness and how the body processes it. Early studies indicated that GS-0415 shows promise in reducing HIV levels in the body, which is crucial for individuals whose HIV is well managed with current treatments. Although more information is needed, these early results offer hope that GS-0415 could aid in managing HIV.678910
Who Is on the Research Team?
Gilead Study Director
Principal Investigator
Gilead Sciences
Are You a Good Fit for This Trial?
This trial is for adults aged 18-65 living with HIV-1 who have had undetectable viral loads and stable antiretroviral treatment for at least a year. Participants must have a healthy immune cell count, weigh between 50–110 kg, and not be taking certain HIV drugs called entry inhibitors.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Single Ascending Dose (SAD) Treatment
Participants receive single escalating doses of GS-0415 or placebo via SC or IV on Day 1
Multiple Ascending Dose (MAD) Treatment
Participants receive escalating doses of GS-0415 or placebo via SC or IV at five different timepoints
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- GS-0415
Trial Overview
The study is testing different single and multiple doses of a new drug called GS-0415 (given by injection or IV) compared to placebo in people with well-controlled HIV. The main goal is to see how safe the drug is and how it behaves in the body.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
Participants will receive escalating doses of GS-0415 via SC or IV at five different timepoints up to Date 57.
Participants will receive placebo to match escalating doses of GS-0415 via SC or IV at five different timepoints up to Day 57.
Participants will receive placebo to match the single escalating doses of GS-0415 via SC or IV on Day 1.
Participants will receive single escalating doses of GS-0415 via SC or IV on Day 1.
Participants will receive single escalating doses of GS-0415 via subcutaneous (SC) or intravenously (IV) on Day 1.
Participants will receive placebo to match the single escalating doses of GS-0415 via SC or IV on Day 1.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Gilead Sciences
Lead Sponsor
Daniel O'Day
Gilead Sciences
Chief Executive Officer since 2019
MBA from Columbia University
Dietmar Berger
Gilead Sciences
Chief Medical Officer
MD and PhD from Albert-Ludwigs University School of Medicine
Citations
Lenacapavir for PrEP (PURPOSE 365 Trial)
Studies found that LEN reduced the risk of HIV infection by 100% in women and 96% in a mostly male group. It is the first treatment to show no infections
Clinical Trials - UC College of Medicine - University of Cincinnati
This is a Phase 1b study testing an investigational drug called GS-0415 in adults with HIV whose virus is already well controlled on HIV ...
3.
journals.plos.org
journals.plos.org/plosone/article/file?type=printable&id=10.1371/journal.pone.0097482Efficacy of Initial Antiretroviral Therapy for HIV-1 Infection in ...
The ACTG A5202 study showed a higher risk of study-defined virological failure with abacavir-lamivudine for viral loads $100,000 copies/mL at.
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clinicalinfo.hiv.gov
clinicalinfo.hiv.gov/sites/g/files/mnhszr391/files/guidelines/archive/guidelines-adult-adolescent-arv-2024-25-04.pdfGuidelines for the Use of Antiretroviral Agents in Adults and ...
Data are insufficient to recommend for or against statin therapy as primary prevention of ASCVD in people with HIV.
The antiretroviral pipeline 2016
Dose-dependent decreases in viral load were reported, and efficacy at the highest BMS-197 dose was similar to that of ART. Adding to the ...
*Public Law 119–75 119th Congress An Act
... HIV prevention educational activities undertaken in connection with United States military training, exercises, and humanitarian assistance ...
Fecal Microbiota Transplantation: An Update on Clinical Practice
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WHO-PQ RECOMMENDED SUMMARY OF PRODUCT ...
Preclinical safety data. In repeat dose toxicology studies in rat and dog, high doses of the 1:1 diastereomeric mixture caused adverse liver (dog) and heart ...
Effectiveness of Progressive Resistive Exercise (PRE) in the ...
HIV is increasingly considered a chronic illness. More individuals are living longer and aging with the health-related consequences associated with HIV and ...
Clinical Trials - UC College of Medicine - University of Cincinnati
This is a Phase 1b study testing an investigational drug called GS-0415 in adults with HIV whose virus is already well controlled on HIV ...
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