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Safety and Biological Activity of Vesatolimod in HIV-1 Infected, Virologically Suppressed Adults

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Gilead Sciences

Status and phase

Completed
Phase 1

Conditions

HIV-1 Infection

Treatments

Drug: Placebo
Drug: ARV regimen
Drug: Vesatolimod

Study type

Interventional

Funder types

Industry

Identifiers

NCT02858401
GS-US-382-1450

Details and patient eligibility

About

The primary objectives of this study are to evaluate the safety and tolerability of escalating, multiple doses of vesatolimod (formerly GS-9620) in HIV-1 infected virologically suppressed adults on antiretroviral therapy (ART) and to evaluate the virologic effect of vesatolimod as measured by changes in plasma HIV-1 RNA.

Enrollment

48 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

  • HIV-1 infection

  • Aged ≥ 18 years at Pre-baseline/Day -13

  • On antiretroviral (ARV) treatment for ≥ 12 consecutive months prior to Pre-Baseline/Day -13

    • The following agents are allowed as part of the current ARV regimen: NRTIs, raltegravir, dolutegravir, rilpivirine, and maraviroc
    • The following agents are NOT allowed as part of the current ARV regimen: HIV protease inhibitors (including low dose ritonavir), cobicistat-containing regimens, elvitegravir, efavirenz, etravirine, and nevirapine
    • A change in ARV regimen ≥ 45 days prior to baseline/Day 1 for reasons other than virologic failure (eg, tolerability, simplification, drug-drug interaction profile) is allowed
  • Plasma HIV-1 RNA < 50 copies/mL at screening

  • Documented plasma HIV-1 RNA levels < 50 copies/mL (according to the local assay being used) for ≥ 12 months preceding the screening visit (measured at least twice using a licensed assay with a lower limit of quantitation of at least 40 copies/mL)

    • Unconfirmed virologic elevations of ≥ 50 copies/mL (transient detectable viremia, or "blip") prior to screening are acceptable. (If the lower limit of detection of the local HIV-1 RNA assay is < 50 copies/mL, the plasma HIV-1 RNA level cannot exceed 50 copies/mL on two consecutive HIV-1 RNA tests)
    • If ART regimen is changed ≥ 60 days prior to Pre-Baseline/Day -13, plasma HIV-1 RNA <50 copies/mL at Pre-baseline/Day -13 visit is required
  • No documented history of resistance to any components of the current ARV regimen

  • Availability of a fully active alternative ARV regimen, in the opinion of the Investigator, in the event of discontinuation of the current ARV regimen with development of resistance

  • Hgb ≥ 11.5 g/dL (males) or ≥ 11 g/dL (females)

  • White blood cells (WBC) ≥ 4,000 cells/μL

  • Platelets ≥ 150,000/mL

  • Absolute neutrophil count (ANC) ≥ 1500 cells/μL

  • CD4 count ≥ 400 cells/μL

  • Albumin ≥ 3.9 g/dL

  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2 × upper limit of the normal range (ULN)

  • Estimated glomerular filtration rate ≥ 60 mL/min

  • No autoimmune disease

Key Exclusion Criteria:

  • Hepatitis B surface antigen (HBsAg) positive

    • Positive anti-HBs antibody and negative HBsAg results are acceptable
  • Hepatitis C antibody (HCVAb) positive

    • Positive anti-HCV antibody and negative HCV polymerase chain reaction (PCR) results are acceptable
  • Documented history of pre-ART CD4 nadir < 200 cells/µL

    • Unknown pre-ART CD4 nadir is acceptable
  • A new AIDS-defining condition diagnosed within 90 days prior to screening

  • Acute febrile illness within 35 days prior to pre-baseline/Day -13

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

48 participants in 10 patient groups, including a placebo group

Vesatolimod 1 mg (Cohort 1)
Experimental group
Description:
Vesatolimod 1 mg for 71 days, while continuing their existing ARV regimen
Treatment:
Drug: ARV regimen
Drug: Vesatolimod
Vesatolimod 2 mg (Cohort 2)
Experimental group
Description:
Vesatolimod 2 mg for 71 days, while continuing their existing ARV regimen
Treatment:
Drug: ARV regimen
Drug: Vesatolimod
Vesatolimod 4 mg (Cohort 3)
Experimental group
Description:
Vesatolimod 4 mg for 71 days, while continuing their existing ARV regimen
Treatment:
Drug: ARV regimen
Drug: Vesatolimod
Vesatolimod 6 mg (Cohort 4)
Experimental group
Description:
Vesatolimod 6 mg for 127 days, while continuing their existing ARV regimen
Treatment:
Drug: ARV regimen
Drug: Vesatolimod
Vesatolimod 8 mg (Cohort 5)
Experimental group
Description:
Vesatolimod 8 mg for 127 days administered following overnight fasting, while continuing their existing ARV regimen
Treatment:
Drug: ARV regimen
Drug: Vesatolimod
Vesatolimod 10 or 12 mg (Cohort 6)
Experimental group
Description:
Vesatolimod 10 or 12 mg for 127 days administered following overnight fasting, while continuing their existing ARV regimen. Participants will receive 3 administrations of 10 mg, followed by 7 administrations of 12 mg (after review of 10 mg safety data)
Treatment:
Drug: ARV regimen
Drug: Vesatolimod
Vesatolimod 12 mg (Optional Cohort 7)
Experimental group
Description:
Vesatolimod up to 12 mg for up to 127 days for up to 10 total doses administered following overnight fasting, while continuing their existing ARV regimen
Treatment:
Drug: ARV regimen
Drug: Vesatolimod
Vesatolimod 6 mg with an acidic solution (Optional Cohort 8)
Experimental group
Description:
Vesatolimod 6 mg for 127 days for up to 10 total doses administered with an acidic solution (cranberry juice), while continuing their existing ARV regimen
Treatment:
Drug: ARV regimen
Drug: Vesatolimod
Vesatolimod up to 12 mg (Cohort 9)
Experimental group
Description:
Vesatolimod up to 12 mg for 127 days for up to 10 total doses administered following a moderate-fat meal, after the review of the data from the highest tolerated fasted dose cohort while continuing their existing ARV regimen
Treatment:
Drug: ARV regimen
Drug: Vesatolimod
Placebo (Cohorts 1-9)
Placebo Comparator group
Description:
Placebo to match vesatolimod for 71 or 127 days, while continuing their existing ARV regimen
Treatment:
Drug: Placebo
Drug: ARV regimen

Trial documents
2

Trial contacts and locations

8

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Data sourced from clinicaltrials.gov

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