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Study to Evaluate the Safety and Efficacy of Lenacapavir in Combination With Other Antiretroviral Agents in People Living With HIV (CALIBRATE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04143594
Recruitment Status : Active, not recruiting
First Posted : October 29, 2019
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

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

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 184 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
Actual Study Start Date : November 22, 2019
Estimated Primary Completion Date : October 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: Lenacapavir, F/TAF, and TAF

Induction: Participants will receive oral lenacapavir 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) lenacapavir 927 mg.

Maintenance: Participants will receive SC lenacapavir 927 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 lenacapavir 927 mg every 6 months (26 weeks) and oral daily TAF 25 mg from Week 80 onwards.

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

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

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

Drug: TAF
Tablets administered without regard to food

Experimental: Lenacapavir, F/TAF, and BIC

Induction: Participants will receive oral lenacapavir 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 lenacapavir 927 mg.

Maintenance: Participants will receive SC lenacapavir 927 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 lenacapavir 927 mg every 6 months (26 weeks) and oral daily bictegravir (BIC) 75 mg from Week 80 onwards.

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

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

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

Drug: BIC
Tablets administered without regard to food

Experimental: Lenacapavir and F/TAF

Participants will receive oral lenacapavir 600 mg at Day 1 and Day 2. On Day 3, participants will begin oral daily lenacapavir 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 lenacapavir 50 mg and oral daily F/TAF 200/25 mg from Week 80 onwards.

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

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 (ARV) naive with no use of any ARV within one month of screening. Use of pre-exposure prophylaxis (PrEP) (any duration), post-exposure prophylaxis (PEP) (any duration), or HIV-1 treatment (< 10 days therapy total) > 1 month prior to screening is permitted
  • HIV-1 RNA ≥ 200 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


Locations
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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    
Other Study ID Numbers: GS-US-200-4334
First Posted: October 29, 2019    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
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