Phase 1
Completed N=53
Study to Evaluate Safety, Pharmacokinetics, and Antiviral Activity of Lenacapavir Administered Subcutaneously in Human Immunodeficiency Virus (HIV) -1 Infected Adults
Source: ClinicalTrials.gov NCT03739866 ↗Enrolled (actual)
53
Serious AEs
3.9%
Results posted
Dec 2020
Primary outcomePrimary: Part A and Part B: Maximum Reduction From Day 1 (Baseline) Through Day 10 in Plasma HIV-1 RNA — -1.35; -1.79; -1.76; -2.20 log10 copies/mL — p=<0.0001
Summary
The primary objectives of this study are:
Part A: To evaluate the short-term antiviral activity of lenacapavir (formerly GS-6207) with respect to the maximum reduction of plasma HIV-1 RNA (log10 copies/mL) from Day 1 through Day 10 compared to placebo in HIV-1 infected adults who are antiretroviral treatment naive or are experienced but capsid inhibitor (CAI) naive.
Part B: To evaluate the short-term antiviral activity of tenofovir alafenamide (TAF) with respect to the maximum reduction of plasma HIV-1 RNA (log10 copies/mL) from Day 1 through Day 10 in HIV-1 infected adult subjects who are antiretroviral treatment naïve or are experienced but without resistance to TAF.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part A and Part B: Maximum Reduction From Day 1 (Baseline) Through Day 10 in Plasma HIV-1 RNA |
-1.35; -1.79; -1.76; -2.20; -2.26; -0.17 | <0.0001 sig |
| SECONDARY Part A and Part B: Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) |
83.3; 100; 83.3; 100; 80; 70 | — |
| SECONDARY Part A and Part B: Percentage of Participants Experiencing Treatment Emergent Laboratory Abnormalities |
83.3; 83.3; 100.0; 66.7; 100.0; 80.0 | — |
| SECONDARY Part A and Part B Pharmacokinetic (PK) Parameter: AUCinf of Lenacapavir, TAF and Its Metabolite TFV |
6564.3; 9124.1; 31537.0; 106041.1; 181861.0; 1270.3 | — |
| SECONDARY Part A and Part B PK Parameter: AUClast of Lenacapavir, TAF and Its Metabolite TFV |
5084.3; 7524.4; 28866.4; 102919.0; 171173.9; 1265.8 | — |
| SECONDARY Part A and Part B PK Parameter: Cmax of Lenacapavir, TAF and Its Metabolite TFV |
3.0; 5.4; 17.1; 60.1; 116.6; 1919.0 | — |
| SECONDARY Part B PK Parameter: AUCinf of TFV-DP Metabolite of TAF |
599.7; 7981.4 | — |
| SECONDARY Part B PK Parameter: AUClast of TFV-DP Metabolite of TAF |
390.9; 7749.3 | — |
| SECONDARY Part B PK Parameter: Cmax of TFV-DP Metabolite of TAF |
8.5; 163.0 | — |
| SECONDARY Part A: Percentage of Participants Ever Achieving HIV-1 RNA < 50 Copies/mL by Day 10 |
0; 16.7; 0; 16.7; 20.0; 0 | — |
| SECONDARY Part A: Number of Participants Experiencing Any Emergence of Capsid Inhibitor Resistance |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Part A: Number of Participants Experiencing Any Emergence of Capsid Inhibitor Resistance |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Part B: Number of Participants Experiencing Any Emergence of TAF Resistance |
— | — |
| SECONDARY Part B: Number of Participants Experiencing Any Emergence of TAF Resistance |
— | — |
Eligibility Criteria
Key Inclusion Criteria
- Plasma HIV-1 RNA ≥ 5, 000 copies/mL but ≤ 400,000 copies/mL and CD4+ cell count > 200 cells/mm^3
- Treatment naive or experienced but CAI (for Part A only) and integrase strand transfer inhibitor (INSTI) naïve, and have not received any antiretroviral therapy (ART) within 12 weeks of screening
- Screening genotype report must show sensitivity to B/F/TAF to allow its initiation on Day 10
- Screening genotype report must show sensitivity to at least one agent in either non-nucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI) class to allow its use as part of standard of care oral antiretroviral treatment in the future
- Have adequate renal function (estimated glomerular filtration rate ≥ 70 mL/min)
- No clinically significant abnormalities in electrocardiography (ECG) at Screening
- Willing to initiate B/F/TAF on Day 10 after completion of all assessments
Key Exclusion Criteria
- Pregnant or lactating females
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT03739866). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.