NCT07719491 · Gilead Sciences
Study of GS-0415 and How It Works in People With HIV
What this study is about
The goals of this clinical study are to learn more about the study drug GS-0415, safety, tolerability, and how the drug moves through the body (PK) of single ascending doses (SAD) and multiple ascending doses (MAD) of injected under the skin (SC) and given through a vein (IV) (IV) GS-0415 in people with HIV-1 (PWH) on antiretroviral treatment.
View original scientific description
The goals of this clinical study are to learn more about the study drug GS-0415, safety, tolerability, and pharmacokinetics (PK) of single ascending doses (SAD) and multiple ascending doses (MAD) of subcutaneous (SC) and intravenous (IV) GS-0415 in people with HIV-1 (PWH) on antiretroviral treatment. The primary objectives of this study are to evaluate the safety and tolerability of escalating, single and multiple subcutaneous (SC) and intravenous (IV) doses of GS-0415, administered in PWH who are virologically suppressed on antiretroviral therapy (ART) and to evaluate the pharmacokinetics (PK) of GS-0415.
Interventions
DRUG
GS-0415
Administered SC or IV
DRUG
GS-0415 Placebo
Administered SC or IV
Primary outcome measures
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs)
Time frame: First dose date up to 99 days
Percentage of Participants Experiencing Clinical Laboratory Abnormalities
Time frame: First dose date up to 99 days
Serum Pharmacokinetic (PK) Parameter (After Single Ascending Dose (SAD)): AUCinf of GS-0145
Time frame: Up to 43 days
AUCinf is defined as the area under the concentration versus time curve extrapolated to infinite time, calculated as AUClast + (Clast/λz).
Serum PK Parameters (SAD): Cmax of GS-0145
Time frame: Up to 43 days
Cmax is defined as the maximum observed concentration of drug.
Serum PK Parameters Multiple Ascending Dose (MAD): Dose 1 and Dose 5: AUCtau of GS-0145
Time frame: Up to 99 days
AUCtau is defined as the area under the concentration versus time curve over the dosing interval.
Serum PK Parameters MAD: Dose 1 and Dose 5: Cmax of GS-0145
Time frame: Up to 99 days
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion 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
Exclusion criteria
- 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
- Have chronic hepatitis B virus (HBV) as determined by either:
- 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 sensitivity or drug allergy ('but not limited to anaphylaxis or drug-induced liver injury) as assessed by the investigator 4.) Known hypersensitivity to the study drugs, their metabolites, or to formulation excipients 5.) Previous or current history of bleeding disorder, platelet disorder including unexplained acute or chronic thrombocytopenia 6.) Autoimmune diseases including Type 1 diabetes mellitus 7.) Serious or active medical or psychiatric illness that would interfere with participant treatment, assessment, or compliance with the protocol. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Where
- Los Angeles, California
- Washington D.C., District of Columbia
- West Palm Beach, Florida
- Las Vegas, Nevada
- Newark, New Jersey
- The Bronx, New York
- Columbus, Ohio
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 1, 2026 · Source of record for eligibility and locations