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Study to Evaluate the Safety and Efficacy of GS-6207 in Combination With Other Antiretroviral Agents in People Living With HIV

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ClinicalTrials.gov Identifier: NCT04143594
Recruitment Status : Not yet recruiting
First Posted : October 29, 2019
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
The primary objective of this study is to evaluate the efficacy of GS-6207 containing regimens in people living with HIV (PLWH).

Condition or disease Intervention/treatment Phase
HIV-1-infection Drug: Oral GS-6207 Drug: F/TAF Drug: Subcutaneous GS-6207 Drug: TAF Drug: BIC Drug: B/F/TAF Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 175 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Randomized, Open Label, Active Controlled Study Evaluating the Safety and Efficacy of Long-acting Capsid Inhibitor GS-6207 in Combination With Other Antiretroviral Agents in People Living With HIV
Estimated Study Start Date : December 2019
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: GS-6207, F/TAF, and TAF

Induction: Participants will receive oral GS-6207 600 mg, 600 mg, and 300 mg at Days 1, 2, and 8, respectively. Participants will also begin oral daily emtricitabine/tenofovir alafenamide (F/TAF) 200/25mg from Day 1 onwards for a total of 28 weeks. On Day 15 participants will receive subcutaneous (SC) GS-6207 900 mg.

Maintenance: Participants will receive SC GS-6207 900 mg at Week 28 and every 26 weeks. Participants will discontinue oral daily F/TAF 200/25 mg at Week 28 and begin taking oral daily TAF 25 mg.

Participants willing to continue the study beyond Week 80 will continue to receive SC GS-6207 900 mg every 6 months (26 weeks) and oral daily TAF 25 mg from Week 80 onwards.

Drug: Oral GS-6207
Tablets administered without regard to food

Drug: F/TAF
Tablets administered without regard to food
Other Name: Descovy®

Drug: Subcutaneous GS-6207
Administered in the abdomen via subcutaneous injections

Drug: TAF
Tablets administered without regard to food

Experimental: GS-6207, F/TAF, and BIC

Induction: Participants will receive oral GS-6207 600 mg, 600 mg, and 300 mg at Days 1, 2, and 8, respectively. Participants will also begin oral daily F/TAF 200/25 mg from Day 1 onward for a total of 28 weeks. On Day 15 participants will receive SC GS-6207 900 mg.

Maintenance: Participants will receive SC GS-6207 900 mg at Week 28 and every 26 weeks. Participants will discontinue oral daily F/TAF 200/25 mg at Week 28 and begin oral daily bictegravir (BIC) 75 mg.

Participants willing to continue the study beyond Week 80 will continue to receive SC GS-6207 900 mg every 6 months (26 weeks) and oral daily bictegravir (BIC) 75 mg from Week 80 onwards.

Drug: Oral GS-6207
Tablets administered without regard to food

Drug: F/TAF
Tablets administered without regard to food
Other Name: Descovy®

Drug: Subcutaneous GS-6207
Administered in the abdomen via subcutaneous injections

Drug: BIC
Tablets administered without regard to food

Experimental: GS-6207 and F/TAF

Participants will receive oral GS-6207 600 mg at Day 1 and Day 2. On Day 3, participants will begin oral daily GS-6207 50 mg. Participants will begin oral daily F/TAF 200/25 mg from Day 1 onwards.

Participants willing to continue the study beyond Week 80 will continue to receive oral daily GS-6207 50 mg and oral daily F/TAF 200/25 mg from Week 80 onwards.

Drug: Oral GS-6207
Tablets administered without regard to food

Drug: F/TAF
Tablets administered without regard to food
Other Name: Descovy®

Active Comparator: B/F/TAF
Participants will receive oral daily bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) 50/200/25 mg at Day 1 and throughout their participation in the study.
Drug: B/F/TAF
Tablets administered without regard to food
Other Name: Biktarvy®




Primary Outcome Measures :
  1. Proportion of Participants with HIV-1 RNA < 50 Copies/mL at Week 54 as Determined by the US FDA-defined Snapshot Algorithm [ Time Frame: Week 54 ]

Secondary Outcome Measures :
  1. Proportion of Participants with HIV-1 RNA < 50 Copies/mL at Week 28 as Determined by the US FDA-defined Snapshot Algorithm [ Time Frame: Week 28 ]
  2. Proportion of Participants with HIV-1 RNA < 50 Copies/mL at Week 38 as Determined by the US FDA-defined Snapshot Algorithm [ Time Frame: Week 38 ]
  3. Proportion of Participants with HIV-1 RNA < 50 Copies/mL at Week 80 as Determined by the US FDA-defined Snapshot Algorithm [ Time Frame: Week 80 ]
  4. Change from Baseline in Log10 HIV-1 RNA at Week 28 [ Time Frame: Baseline; Week 28 ]
  5. Change from Baseline in Log10 HIV-1 RNA at Week 38 [ Time Frame: Baseline; Week 38 ]
  6. Change from Baseline in Log10 HIV-1 RNA at Week 54 [ Time Frame: Baseline; Week 54 ]
  7. Change from Baseline in Log10 HIV-1 RNA at Week 80 [ Time Frame: Baseline; Week 80 ]
  8. Change from Baseline in CD4+ Cell Count at Week 28 [ Time Frame: Baseline; Week 28 ]
  9. Change from Baseline in CD4+ Cell Count at Week 38 [ Time Frame: Baseline; Week 38 ]
  10. Change from Baseline in CD4+ Cell Count at Week 54 [ Time Frame: Baseline; Week 54 ]
  11. Change from Baseline in CD4+ Cell Count at Week 80 [ Time Frame: Baseline; Week 80 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Antiretroviral naive (≤ 10 days of therapy prior to screening with any antiretroviral agent following a diagnosis of HIV-1 infection) except the use for pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP), up to one month prior to screening
  • HIV-1 RNA ≥ 500 copies/mL at screening
  • CD4+ cell count ≥ 200 cells/microliter at screening

Key Exclusion Criteria:

  • Current Hepatitis B Virus (HBV) or Hepatitis C virus (HCV) infection

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04143594


Contacts
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Contact: Gilead Clinical Study Information Center 1-833-445-3230 (GILEAD-0) GileadClinicalTrials@gilead.com

Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences

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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT04143594     History of Changes
Other Study ID Numbers: GS-US-200-4334
First Posted: October 29, 2019    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents