MedPath

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

Phase 2
Completed
Conditions
HIV-1-infection
Interventions
Drug: Oral Lenacapavir
Drug: B/F/TAF
Drug: F/TAF
Drug: Subcutaneous Lenacapavir
Drug: TAF
Drug: BIC
Registration Number
NCT04143594
Lead Sponsor
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 human immunodeficiency virus (HIV) (PLWH).

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
183
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 ribonucleic acid (RNA) ≥ 200 copies/mL at screening
  • Cluster Determinant 4+ (CD4+) cell count ≥ 200 cells/microliter at screening

Key

Read More
Exclusion Criteria
  • Current Hepatitis B Virus (HBV) or Hepatitis C virus (HCV) infection

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

Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Lenacapavir, F/TAF, and TAFSubcutaneous LenacapavirInduction phase: Participants will receive lenacapavir (LEN) 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus emtricitabine/ tenofovir alafenamide (F/TAF) (200/25 mg) fixed-dose combination (FDC) tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via subcutaneous (SC) injection on Day 15. Maintenance phase: Participants will receive LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards.
Lenacapavir, F/TAF, and BICOral LenacapavirInduction phase: Participants will receive LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants will receive LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus bictegravir (BIC) 75 mg tablets once daily orally at Week 28 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards.
Lenacapavir, F/TAF, and TAFOral LenacapavirInduction phase: Participants will receive lenacapavir (LEN) 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus emtricitabine/ tenofovir alafenamide (F/TAF) (200/25 mg) fixed-dose combination (FDC) tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via subcutaneous (SC) injection on Day 15. Maintenance phase: Participants will receive LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards.
Lenacapavir, F/TAF, and TAFF/TAFInduction phase: Participants will receive lenacapavir (LEN) 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus emtricitabine/ tenofovir alafenamide (F/TAF) (200/25 mg) fixed-dose combination (FDC) tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via subcutaneous (SC) injection on Day 15. Maintenance phase: Participants will receive LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards.
Lenacapavir, F/TAF, and TAFTAFInduction phase: Participants will receive lenacapavir (LEN) 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus emtricitabine/ tenofovir alafenamide (F/TAF) (200/25 mg) fixed-dose combination (FDC) tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via subcutaneous (SC) injection on Day 15. Maintenance phase: Participants will receive LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards.
Lenacapavir, F/TAF, and BICF/TAFInduction phase: Participants will receive LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants will receive LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus bictegravir (BIC) 75 mg tablets once daily orally at Week 28 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards.
Lenacapavir, F/TAF, and BICSubcutaneous LenacapavirInduction phase: Participants will receive LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants will receive LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus bictegravir (BIC) 75 mg tablets once daily orally at Week 28 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards.
Lenacapavir, F/TAF, and BICBICInduction phase: Participants will receive LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants will receive LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus bictegravir (BIC) 75 mg tablets once daily orally at Week 28 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards.
Lenacapavir and F/TAFOral LenacapavirInduction phase: Participants will receive LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants will receive LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus bictegravir (BIC) 75 mg tablets once daily orally at Week 28 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards.
Lenacapavir and F/TAFF/TAFInduction phase: Participants will receive LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants will receive LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus bictegravir (BIC) 75 mg tablets once daily orally at Week 28 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards.
B/F/TAFB/F/TAFParticipants will receive bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) FDC tablets once daily orally from Day 1 and throughout their participation in the study up to Week 80
Primary Outcome Measures
NameTimeMethod
Percentage of Participants With Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) < 50 Copies/mL at Week 54 as Determined by the United States Food and Drug Administration (US FDA)-Defined Snapshot AlgorithmWeek 54

The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 54 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Week 54 window was between Day 323 and 413 (inclusive). Percentages were rounded off.

Secondary Outcome Measures
NameTimeMethod
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 28 as Determined by the US FDA-defined Snapshot AlgorithmWeek 28

The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 28 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Week 28 window was between Days 176 and 231 (inclusive). Percentages were rounded off.

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 38 as Determined by the US FDA-defined Snapshot AlgorithmWeek 38

The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 38 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Week 38 window was between Days 232 and 322 (inclusive). Percentages were rounded off.

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 80 as Determined by the US FDA-defined Snapshot AlgorithmWeek 80

The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 80 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. The Week 80 window was between Days 505 and 595 (inclusive). Percentages were rounded off.

Change From Baseline in Log10 HIV-1 RNA at Week 28Baseline, Week 28
Change From Baseline in Log10 HIV-1 RNA at Week 38Baseline, Week 38
Change From Baseline in Log10 HIV-1 RNA at Week 54Baseline, Week 54
Change From Baseline in Log10 HIV-1 RNA at Week 80Baseline, Week 80
Change From Baseline in Clusters of Differentiation 4+ (CD4+) Cell Count at Week 28Baseline, Week 28
Change From Baseline in CD4+ Cell Count at Week 38Baseline, Week 38
Change From Baseline in CD4+ Cell Count at Week 54Baseline, Week 54
Change From Baseline in CD4+ Cell Count at Week 80Baseline, Week 80
Percentage of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)Up to 174.9 weeks

TEAEs were defined as 1 or both of any AEs leading to premature discontinuation of study drug, or any AEs with an onset date on or after the study drug start date and no later than the last exposure date after permanent discontinuation of the study drug. Percentages were rounded off.

Percentage of Participants Who Experienced Maximum Postbaseline Laboratory AbnormalitiesUp to 174.9 weeks

Treatment-emergent laboratory abnormalities were defined as values that increase at least 1 toxicity grade from baseline at any postbaseline visit, up to last exposure date for participants who permanently discontinued study drug. Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: life-threatening. Percentages were rounded off.

Pharmacokinetics (PK) of LEN: Plasma LEN Pre-dose Concentrations for SC LENDay 2, 8, Day 1 SC (Day 15), Week 28 and Week 54
PK of LEN : Plasma LEN Single Anytime Concentrations for the Oral LEN + DVYDay 2, 8, 15 , Week 28 and Week 54
PK of TAF (Tenofovir Alafenamide) and TFV (Tenofovir): Area Under the Concentration Versus Time Curve (AUClast) on Day 10 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose on Day 1

AUClast is defined as area under the concentration versus time curve from time zero to the last quantifiable concentration. A PK substudy was conducted in at least 10 participants in each of the treatment groups receiving SC LEN (Treatment Groups 1 and 2) and at least 15 participants in the treatment group receiving oral LEN (Treatment Group 3). Key PK parameters of TAF and TFV were summarized for participants in the PK Sub study Analysis Set by treatment group, analyte and visit. PK substudy analysis was conducted for Group 1 and 2 on Day 1.

PK of TAF and TFV (Tenofovir): Maximum Observed Concentration of Drug (Cmax) on Day 10 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose on Day 1

Cmax is defined as the maximum observed concentration of drug. A PK substudy was conducted in at least 10 participants in each of the treatment groups receiving SC LEN (Treatment Groups 1 and 2). Key PK parameters of TAF and TFV were summarized for participants in the PK Sub study Analysis Set by treatment group, analyte and visit. PK substudy analysis was conducted for Group 1 and 2 on Day 1.

PK of TAF and TFV: Time (Observed Time Point) of Cmax (Tmax) on Day 10 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose on Day 1

Tmax is defined as the time (observed time point) of Cmax. A PK substudy was conducted in at least 10 participants in each of the treatment groups receiving SC LEN (Treatment Groups 1 and 2). Key PK parameters of TAF and TFV were summarized for participants in the PK Sub study Analysis Set by treatment group, analyte and visit. PK substudy analysis was conducted for Group 1 and 2 on Day 1.

PK of TFV: Last Observed Quantifiable Concentration of the Drug (Clast) on Day 10 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose on Day 1

Clast is defined as the last observable concentration of drug. A PK substudy was conducted in at least 10 participants in each of the treatment groups receiving SC LEN (Treatment Groups 1 and 2). Key PK parameters of TFV were summarized for participants in the PK Sub study Analysis Set by treatment group, analyte and visit. PK sub study analysis was conducted for Group 1 and 2 on Day 1.

PK of TAF and TFV: AUClast at Weeks 16, 22, or 280 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose

AUClast is defined as area under the concentration versus time curve from time zero to the last quantifiable concentration. A PK substudy was conducted in at least 15 participants in the treatment group receiving oral LEN (Treatment Group 3). Key PK parameters of TAF and TFV were summarized for participants in the PK Sub study Analysis Set by treatment group, analyte and visit. For each participant, PK samples were taken at only one of the three possible visits: Weeks 16, 22, or 28. The PK results were combined and summarized without regard to specific study visit within the range of prespecified study visits.

PK of TAF and TFV: Cmax at Weeks 16, 22, or 280 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose

Cmax is defined as the maximum observed concentration of drug. A PK substudy was conducted in at least 15 participants in the treatment group receiving oral LEN (Treatment Group 3). Key PK parameters of TAF and TFV were summarized for participants in the PK Sub study Analysis Set by treatment group, analyte and visit. For each participant, PK samples were taken at only one of the three possible visits: Weeks 16, 22, or 28. The PK results were combined and summarized without regard to specific study visit within the range of prespecified study visits.

PK of TAF and TFV: Tmax at Weeks 16, 22, or 280 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose

Tmax is defined as the time (observed time point) of Cmax. A PK substudy was conducted in at least 15 participants in the treatment group receiving oral LEN (Treatment Group 3). Key PK parameters of TAF and TFV were summarized for participants in the PK Sub study Analysis Set by treatment group, analyte and visit. For each participant, PK samples were taken at only one of the three possible visits: Weeks 16, 22, or 28. The PK results were combined and summarized without regard to specific study visit within the range of prespecified study visits.

PK of TFV: Clast at Weeks 16, 22, or 280 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose

Clast is defined as the last observable concentration of drug. A PK substudy was conducted in at least 15 participants in the treatment group receiving oral LEN (Treatment Group 3). Key PK parameters of TFV was summarized for participants in the PK Sub study Analysis Set by treatment group, analyte and visit. For each participant, PK samples were taken at only one of the three possible visits: Weeks 16, 22, or 28. The PK results were combined and summarized without regard to specific study visit within the range of prespecified study visits.

PK of TAF: AUClast at Week 380 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose

AUClast is defined as area under the concentration versus time curve from time zero to the last quantifiable concentration. A PK substudy was conducted in at least 10 participants in each of the treatment groups receiving SC LEN (Treatment Groups 1 and 2). Key PK parameters of TAF was summarized for participants in the PK Sub study Analysis Set by treatment group, analyte and visit. PK substudy analysis was conducted for Group 1 at Week 38.

PK of TAF: Cmax at Week 380 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose

Cmax is defined as the maximum observed concentration of drug. A PK substudy was conducted in at least 10 participants in each of the treatment groups receiving SC LEN (Treatment Groups 1 and 2). Key PK parameters of TAF was summarized for participants in the PK Sub study Analysis Set by treatment group, analyte and visit. PK substudy analysis was conducted for Group 1 at Week 38.

PK of TAF: Tmax at Week 380 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose

Tmax is defined as the time (observed time point) of Cmax. A PK substudy was conducted in at least 10 participants in each of the treatment groups receiving SC LEN (Treatment Groups 1 and 2). Key PK parameters of TAF was summarized for participants in the PK Sub study Analysis Set by treatment group, analyte and visit. PK substudy analysis was conducted for Group 1 at Week 38.

PK of Tenofovir Diphosphate (TFV-DP): AUClast at Weeks 4, 10, 16, or 220 hours (Predose) and at 1, 2, and 6 hours postdose

AUClast is defined as area under the concentration versus time curve from time zero to the last quantifiable concentration. A peripheral blood mononuclear cell (PBMC) substudy was conducted in a total of approximately 15 participants in Treatment Groups 1 and 2. For each participant, PK samples were taken at only one of the four possible visits: Weeks 4, 10, 16, or 22. A 12-hour postdose sample was collected, if possible. The PK results were combined and summarized without regard to specific study visit within the range of prespecified study visits.

PK of TFV-DP: Cmax at Weeks 4, 10, 16, or 220 hours (Predose) and at 1, 2, and 6 hours postdose

Cmax is defined as the maximum observed concentration of drug. A PBMC substudy was conducted in a total of approximately 15 participants in Treatment Groups 1 and 2. For each participant, PK samples were taken at only one of the four possible visits: Weeks 4, 10, 16, or 22. A 12-hour postdose sample was collected, if possible. The PK results were combined and summarized without regard to specific study visit within the range of prespecified study visits.

PK of TFV-DP: Tmax at Weeks 4, 10, 16, or 220 hours (Predose) and at 1, 2, and 6 hours postdose

Tmax is defined as the time (observed time point) of Cmax. A PBMC substudy was conducted in a total of approximately 15 participants in Treatment Groups 1 and 2. For each participant, PK samples were taken at only one of the four possible visits: Weeks 4, 10, 16, or 22. A 12-hour postdose sample was collected, if possible. The PK results were combined and summarized without regard to specific study visit within the range of prespecified study visits.

PK of Bictegravir (BIC): AUClast at Week 380 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose

AUClast is defined as area under the concentration versus time curve from time zero to the last quantifiable concentration. A PK substudy was conducted in at least 10 participants in each of the treatment groups receiving SC LEN (Treatment Groups 1 and 2). At Week 38, samples were analyzed for BIC only in Treatment Group 2.

PK of BIC: Cmax at Week 380 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose

Cmax is defined as the maximum observed concentration of drug. A PK substudy was conducted in at least 10 participants in each of the treatment groups receiving SC LEN (Treatment Groups 1 and 2). At Week 38, samples were analyzed for BIC only in Treatment Group 2.

PK of BIC: Tmax at Week 380 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose

Tmax is defined as the time (observed time point) of Cmax. A PK substudy was conducted in at least 10 participants in each of the treatment groups receiving SC LEN (Treatment Groups 1 and 2). At Week 38, samples were analyzed for BIC only in Treatment Group 2.

PK of BIC: Clast at Week 380 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose

Clast is defined as the last observable concentration of drug. A PK substudy was conducted in at least 10 participants in each of the treatment groups receiving SC LEN (Treatment Groups 1 and 2). At Week 38, samples were analyzed for BIC only in Treatment Group 2.

Trial Locations

Locations (53)

Howard Brown Health Center

🇺🇸

Chicago, Illinois, United States

Northstar Healthcare

🇺🇸

Chicago, Illinois, United States

Case Clinical Research Site/University Hospitals Cleveland Medical Center

🇺🇸

Cleveland, Ohio, United States

AHF-The Kinder Medical Group

🇺🇸

Miami, Florida, United States

Indiana University Infectious Diseases Research

🇺🇸

Indianapolis, Indiana, United States

The Crofoot Research Center, Inc.

🇺🇸

Houston, Texas, United States

Valleywise Community Health Center - McDowell

🇺🇸

Phoenix, Arizona, United States

Pueblo Family Physicians

🇺🇸

Phoenix, Arizona, United States

Ruane Clinical Research Group Inc

🇺🇸

Los Angeles, California, United States

Mills Clinical Research at Men's Health Foundation

🇺🇸

Los Angeles, California, United States

Eisenhower Health Center at Rimrock

🇺🇸

Palm Springs, California, United States

Georgetown University Hospital

🇺🇸

Washington, District of Columbia, United States

Midland Florida Clinical Research Center, LLC

🇺🇸

DeLand, Florida, United States

Midway Immunology and Research Center

🇺🇸

Fort Pierce, Florida, United States

Washington Health Institute

🇺🇸

Washington, District of Columbia, United States

August University Medical Center

🇺🇸

Augusta, Georgia, United States

Mercer University, Department of Internal Medicine

🇺🇸

Macon, Georgia, United States

Allegheny Health Network

🇺🇸

Pittsburgh, Pennsylvania, United States

University of Cincinnati

🇺🇸

Cincinnati, Ohio, United States

Prism Health North Texas

🇺🇸

Dallas, Texas, United States

Peter Shalit, M.D.

🇺🇸

Seattle, Washington, United States

DCOL Center for Clinical Research

🇺🇸

Longview, Texas, United States

Texas Centers for Infectious Disease Associates

🇺🇸

Fort Worth, Texas, United States

Clinical Alliance for Research & Education - Infectious Diseases, LLC (CARE-ID)

🇺🇸

Annandale, Virginia, United States

Denver Public Health

🇺🇸

Denver, Colorado, United States

Chatham County Health Department

🇺🇸

Savannah, Georgia, United States

Infectious Disease Specialists of Atlanta

🇺🇸

Decatur, Georgia, United States

Rosedale Infectious Diseases

🇺🇸

Huntersville, North Carolina, United States

Be Well Medical Center

🇺🇸

Berkley, Michigan, United States

AHF-Midtown

🇺🇸

New York, New York, United States

St. Jude Children's Research Hospital

🇺🇸

Memphis, Tennessee, United States

St Hope Foundation

🇺🇸

Bellaire, Texas, United States

The Ohio State University Medical Center

🇺🇸

Columbus, Ohio, United States

Instituto Dominicano de Estudios Virológicos (IDEV)

🇩🇴

Santo Domingo, Dominican Republic

HOPE Clinical Research

🇵🇷

San Juan, Puerto Rico

Whitman-Walker Institute, Inc.

🇺🇸

Washington, District of Columbia, United States

Triple O Research Institute, P.A.

🇺🇸

West Palm Beach, Florida, United States

Atlanta ID Group, PC

🇺🇸

Atlanta, Georgia, United States

MultiCare Rockwood HIV Critical Care Clinic

🇺🇸

Spokane, Washington, United States

Floridian Clinical Research

🇺🇸

Hialeah, Florida, United States

North Texas Infectious Diseases Consultants, P.A.

🇺🇸

Dallas, Texas, United States

AIDS Healthcare Foundation - South Beach

🇺🇸

Miami Beach, Florida, United States

St. John Newland Medical Associates

🇺🇸

Southfield, Michigan, United States

East Carolina University, The Brody School of Medicine

🇺🇸

Greenville, North Carolina, United States

Clinical Research Puerto Rico

🇵🇷

San Juan, Puerto Rico

Proyecto ACTU, School of Medicine, University of Puerto Rico

🇵🇷

San Juan, Puerto Rico

University of Colorado, Denver, University of Colorado Hospital

🇺🇸

Aurora, Colorado, United States

Yale University; School of Medicine

🇺🇸

New Haven, Connecticut, United States

Orlando Immunology Center

🇺🇸

Orlando, Florida, United States

St. Joseph's Hospital Comprehensive Research Institute

🇺🇸

Tampa, Florida, United States

KC CARE Health Center

🇺🇸

Kansas City, Missouri, United States

Central Texas Clinical Research

🇺🇸

Austin, Texas, United States

Montefiore Medical Center

🇺🇸

Bronx, New York, United States

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