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Study of GS-0415 and How It Works in People With HIV

ConditionHIV -1 Infection
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorGilead Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • GS-0415

    Drug

    Administered SC or IV

  • GS-0415 Placebo

    Drug

    Administered SC or IV

Treatment groups

112 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Group A Single Ascending Dose (SAD): GS-0415Experimental treatment 1 intervention
Group B: Group A SAD: PlaceboExperimental treatment 1 intervention
Group C: Group B SAD: GS-0415Experimental treatment 1 intervention
Group D: Group B SAD: PlaceboExperimental treatment 1 intervention
Group E: Group C Multiple Ascending Dose (MAD): GS-0415Experimental treatment 1 intervention
Group F: Group C MAD: PlaceboExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs)

Time frame
First dose date up to 99 days
2

Percentage of Participants Experiencing Clinical Laboratory Abnormalities

Time frame
First dose date up to 99 days
3

Serum Pharmacokinetic (PK) Parameter (After Single Ascending Dose (SAD)): AUCinf of GS-0145

AUCinf is defined as the area under the concentration versus time curve extrapolated to infinite time, calculated as AUClast + (Clast/λz).

Time frame
Up to 43 days
4

Serum PK Parameters (SAD): Cmax of GS-0145

Cmax is defined as the maximum observed concentration of drug.

Time frame
Up to 43 days

Secondary outcomes

1

Percentages of participants With of Treatment-Emergent Anti-GS-0415 Antibodies

Time frame
Up to 99 days
2

Percentages of participants With Virological Rebound (Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) ≥ 50 copies/mL)

Time frame
Up to 99 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Gilead Sciences

Lead sponsor

Source ClinicalTrials.gov
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