NCT03739866

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 14, 2018

Completed
12 days until next milestone

Study Start

First participant enrolled

November 26, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2020

Completed
6 months until next milestone

Results Posted

Study results publicly available

December 9, 2020

Completed
Last Updated

April 9, 2021

Status Verified

March 1, 2021

Enrollment Period

12 months

First QC Date

November 2, 2018

Results QC Date

November 12, 2020

Last Update Submit

March 16, 2021

Conditions

HIV-1 Infection

Outcome Measures

Primary Outcomes (1)

  • Part A and Part B: Maximum Reduction From Day 1 (Baseline) Through Day 10 in Plasma HIV-1 RNA

    Maximum reduction is defined as the minimum of change from baseline in plasma HIV-1 RNA (i.e. smallest change in HIV-RNA from baseline).

    Day 1 through Day 10

Secondary Outcomes (13)

  • Part A and Part B: Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs)

    Day 1 through 225 days

  • Part A and Part B: Percentage of Participants Experiencing Treatment Emergent Laboratory Abnormalities

    Day 1 through 225 days

  • Part A and Part B Pharmacokinetic (PK) Parameter: AUCinf of Lenacapavir, TAF and Its Metabolite TFV

    Part A: 0 (predose),1,2,4,8,12,24 h postdose on Day 1, anytime on Days 3,4,7,8,9,10,14,29,43,57,85,113,141,169,197,225; Part B: 0 (predose),0.5,1,2,3,4,6,8,10,12,24 and 48 h postdose on Day 1, approximately Day 1 predose time on Days 4,5,6,7,8,9,10

  • Part A and Part B PK Parameter: AUClast of Lenacapavir, TAF and Its Metabolite TFV

    Part A: 0 (predose),1,2,4,8,12,24 h postdose on Day 1, anytime on Days 3,4,7,8,9,10,14,29,43,57,85,113,141,169,197,225; Part B: 0 (predose),0.5,1,2,3,4,6,8,10,12,24 and 48 h postdose on Day 1, approximately Day 1 predose time on Days 4,5,6,7,8,9,10

  • Part A and Part B PK Parameter: Cmax of Lenacapavir, TAF and Its Metabolite TFV

    Part A: 0 (predose),1,2,4,8,12,24 h postdose on Day 1, anytime on Days 3,4,7,8,9,10,14,29,43,57,85,113,141,169,197,225; Part B: 0 (predose),0.5,1,2,3,4,6,8,10,12,24 and 48 h postdose on Day 1, approximately Day 1 predose time on Days 4,5,6,7,8,9,10

  • +8 more secondary outcomes

Study Arms (8)

Part A: Lenacapavir 20 mg

EXPERIMENTAL

Participants will receive single dose of lenacapavir 20 mg on Day 1 followed by bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) as per standard-care therapy starting on Day 10 through Day 225.

Drug: LenacapavirDrug: B/F/TAF

Part A: Lenacapavir 50 mg

EXPERIMENTAL

Participants will receive single dose of lenacapavir 50 mg on Day 1 followed by B/F/TAF as per standard-care therapy starting on Day 10 through Day 225.

Drug: LenacapavirDrug: B/F/TAF

Part A: Lenacapavir 150 mg

EXPERIMENTAL

Participants will receive single dose of lenacapavir 150 mg on Day 1 followed by B/F/TAF as per standard-care therapy starting on Day 10 through Day 225.

Drug: LenacapavirDrug: B/F/TAF

Part A: Lenacapavir 450 mg

EXPERIMENTAL

Participants will receive single dose of lenacapavir 450 mg on Day 1 followed by B/F/TAF as per standard-care therapy starting on Day 10 through Day 225.

Drug: LenacapavirDrug: B/F/TAF

Part A: Lenacapavir 750 mg

EXPERIMENTAL

Participants will receive single dose of lenacapavir 750 mg on Day 1 followed by B/F/TAF as per standard-care therapy starting on Day 10 through Day 225.

Drug: LenacapavirDrug: B/F/TAF

Part A: Placebo

PLACEBO COMPARATOR

Participants will receive single dose of placebo matched to lenacapavir on Day 1 followed by B/F/TAF as per standard-care therapy starting on Day 10 through Day 225.

Drug: PlaceboDrug: B/F/TAF

Part B: TAF 200 mg

EXPERIMENTAL

Participants will receive a single dose of TAF 200 mg on Day 1 followed by B/F/TAF as per standard-care therapy starting on Day 10 through Day 225.

Drug: B/F/TAFDrug: TAF

Part B: TAF 600 mg

EXPERIMENTAL

Participants will receive a single dose of TAF 600 mg on Day 1 followed by B/F/TAF as per standard-care therapy starting on Day 10 through Day 225.

Drug: B/F/TAFDrug: TAF

Interventions

LenacapavirDRUG

Administered subcutaneously in the abdomen

Also known as: GS-6207
Part A: Lenacapavir 150 mgPart A: Lenacapavir 20 mgPart A: Lenacapavir 450 mgPart A: Lenacapavir 50 mgPart A: Lenacapavir 750 mg
PlaceboDRUG

Administered subcutaneously in the abdomen

Part A: Placebo
B/F/TAFDRUG

50/200/25 mg tablets administered orally once daily

Also known as: Biktarvy®
Part A: Lenacapavir 150 mgPart A: Lenacapavir 20 mgPart A: Lenacapavir 450 mgPart A: Lenacapavir 50 mgPart A: Lenacapavir 750 mgPart A: PlaceboPart B: TAF 200 mgPart B: TAF 600 mg
TAFDRUG

Tablets administered orally

Part B: TAF 200 mgPart B: TAF 600 mg

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnant or lactating females

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Ruane Clinical Research Group, Inc.

Los Angeles, California, 90036, United States

Location

Mills Clinical Research

Los Angeles, California, 90069, United States

Location

One Community

Sacramento, California, 95817, United States

Location

The Lundquist Institute for BioMedical Innovation at Harbor-UCLA Medical Center

Torrance, California, 90502, United States

Location

Midway Immunology and Research Center

Ft. Pierce, Florida, 34982, United States

Location

Orlando Immunology Center PA

Orlando, Florida, 32803-1851, United States

Location

Triple O Research Institute, P.A.

West Palm Beach, Florida, 33401, United States

Location

Be Well Medical Center

Berkley, Michigan, 48072-3436, United States

Location

AIDS Arms, Inc., DBA Prism Health North Texas

Dallas, Texas, 75208, United States

Location

North Texas Infectious Diseases Consultants, P.A.

Dallas, Texas, 75246, United States

Location

Tarrant County Infectious Disease Associates

Fort Worth, Texas, 76104, United States

Location

The Crofoot Research Center, INC (dba Gordon E. Crofoot MD PA)

Houston, Texas, 77098, United States

Location

Related Publications (5)

  • Daar ES, McDonald C, Crofoot G, Ruane P, Sinclair G, Begley R, et al. Dose-response relationship of subcutaneous long-acting HIV capsid inhibitor GS-6207 [Poster]. Presented at: Conference on Retroviruses and Opportunistic Infections; 2020 March 8-11; Boston, MA, USA

    RESULT

  • Daar ES, McDonald C, Crofoot G, Ruane P, Sinclair G, Patel H, et al. Single doses of long acting capsid inhibitor GS-6207 administered by subcutaneous injection are safe and efficacious in people living with HIV [Poster]. Presented at: 17th European AIDS Conference; 2019 November 6-9; Basel, Switzerland.

    RESULT

  • Daar ES, McDonald C, Crofoot G, Ruane P, Sinclair G, Patel H, et al. Safety and antiviral activity over 10 days following a single dose of subcutaneous GS-6207, a first-in-class, long acting HIV capsid inhibitor in people living with HIV [Poster]. Presented at: 10th IAS Conference on HIV Science; 2019 21-24 July; Mexico City, Mexico.

    RESULT

  • Link JO, Rhee MS, Tse WC, Zheng J, Somoza JR, Rowe W, Begley R, Chiu A, Mulato A, Hansen D, Singer E, Tsai LK, Bam RA, Chou CH, Canales E, Brizgys G, Zhang JR, Li J, Graupe M, Morganelli P, Liu Q, Wu Q, Halcomb RL, Saito RD, Schroeder SD, Lazerwith SE, Bondy S, Jin D, Hung M, Novikov N, Liu X, Villasenor AG, Cannizzaro CE, Hu EY, Anderson RL, Appleby TC, Lu B, Mwangi J, Liclican A, Niedziela-Majka A, Papalia GA, Wong MH, Leavitt SA, Xu Y, Koditek D, Stepan GJ, Yu H, Pagratis N, Clancy S, Ahmadyar S, Cai TZ, Sellers S, Wolckenhauer SA, Ling J, Callebaut C, Margot N, Ram RR, Liu YP, Hyland R, Sinclair GI, Ruane PJ, Crofoot GE, McDonald CK, Brainard DM, Lad L, Swaminathan S, Sundquist WI, Sakowicz R, Chester AE, Lee WE, Daar ES, Yant SR, Cihlar T. Clinical targeting of HIV capsid protein with a long-acting small molecule. Nature. 2020 Aug;584(7822):614-618. doi: 10.1038/s41586-020-2443-1. Epub 2020 Jul 1.

    PMID: 32612233RESULT

  • Margot N, Ram R, Parvangada P, Martin R, Hyland R, Rhee M, Callebaut C. Lenacapavir resistance analysis in a phase Ib clinical proof-of-concept study [oral]. Presented at: HIV Glasgow; 2020 October 5 - 8; Virtual.

    RESULT

MeSH Terms

Interventions

lenacapavirbictegravir, emtricitabine, tenofovir alafenamide, drug combination

Results Point of Contact

Title
Gilead Clinical Study Information Center
Organization
Gilead Sciences
GileadClinicalTrials@gilead.com
1-833-445-3230 (GILEAD-0)

Study Officials

  • Gilead Study Director

    Gilead Sciences

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2018

First Posted

November 14, 2018

Study Start

November 26, 2018

Primary Completion

November 14, 2019

Study Completion

June 15, 2020

Last Updated

April 9, 2021

Results First Posted

December 9, 2020

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

US(12)