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Conditions: HIV Infections
Interventions: Oral Cabotegravir (CAB), Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Long-Acting Injectable Cabotegravir (CAB LA), VRC07-523LS, Standard of Care (SOC) ART; Drug · Biological
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID); NIH
Eligibility: 18 Years and older
Enrollment: 75 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2019 – 2024
U.S. locations: 17
States / cities: Birmingham, Alabama • San Diego, California • San Francisco, California + 12 more

Conditions: HIV Infections
Interventions: Cabotegravir (CAB) tablet, CAB LA, Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) tablet; Drug
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID); NIH
Eligibility: Up to 17 Years · Male only
Enrollment: 9 participants
Healthy volunteers: Accepts healthy volunteers
Timeline: 2020 – 2023
U.S. locations: 4
States / cities: Aurora, Colorado • Chicago, Illinois • Boston, Massachusetts + 1 more

Conditions: HIV Infections
Interventions: Cabotegravir Oral Tablet, TDF/FTC tablets, Placebo for TDF/FTC tablets, Placebo for cabotegravir oral tablet, CAB LA, Placebo for CAB LA; Drug
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID); NIH
Eligibility: 18 Years and older
Enrollment: 4,570 participants
Healthy volunteers: Accepts healthy volunteers
Timeline: 2016 – 2025
U.S. locations: 27
States / cities: Birmingham, Alabama • Los Angeles, California • Oakland, California + 20 more

Conditions: Infection, Human Immunodeficiency Virus
Interventions: GSK1265744 Reference formulation, GSK1265744 New formulation 1, GSK1265744 New formulation 2; Drug
Lead sponsor: ViiV Healthcare; Industry
Eligibility: 18 Years to 65 Years
Enrollment: 24 participants
Healthy volunteers: Accepts healthy volunteers
Timeline: 2014
U.S. locations: 1
States / cities: Overland Park, Kansas

Conditions: HIV-associated Lipodystrophy Syndrome
Interventions: GSK1265744B (sodium salt) containing 14C-GSK1265744B, 150 mg GSK1265744B, Placebo; Drug
Lead sponsor: ViiV Healthcare; Industry
Eligibility: 18 Years to 60 Years
Enrollment: 16 participants
Healthy volunteers: Accepts healthy volunteers
Timeline: 2013
U.S. locations: 1
States / cities: Overland Park, Kansas

Conditions: HIV Infections
Interventions: Cabotegravir sodium (Oral Lead In), Cabotegravir 400 mg/mL, Cabotegravir 200 mg/mL, Topical Non-steroidal anti-inflammatory drug (NSAID), Topical steroid, Topical NSAID placebo, Recombinant human hyaluronidase PH20 (rHuPH20), Topical steroid placebo; Drug
Lead sponsor: ViiV Healthcare; Industry
Eligibility: 18 Years to 50 Years
Enrollment: 138 participants
Healthy volunteers: Accepts healthy volunteers
Timeline: 2020 – 2023
U.S. locations: 4
States / cities: Orlando, Florida • Las Vegas, Nevada • Berlin, New Jersey + 1 more

Conditions: HIV Infection, Infection, Human Immunodeficiency Virus
Interventions: GSK1265744 10 mg oral solution, GSK1265744 5 mg tablet; Drug
Lead sponsor: ViiV Healthcare; Industry
Eligibility: 18 Years to 55 Years
Enrollment: 45 participants
Healthy volunteers: Accepts healthy volunteers
Timeline: 2008
U.S. locations: 1
States / cities: Buffalo, New York

Conditions: Infection, Human Immunodeficiency Virus, HIV Infections
Interventions: GSK1265744 10 mg, GSK1265744 30 mg, GSK1265744 60 mg, Efavirenz 600 mg, Rilpivirine 25 mg, Placebo, Abacavir/Lamivudine (ABC/3TC) or Tenofovir/Emtricitabine (TDF/FTC); Drug
Lead sponsor: ViiV Healthcare; Industry
Eligibility: 18 Years and older
Enrollment: 244 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2012 – 2019
U.S. locations: 40
States / cities: Birmingham, Alabama • Phoenix, Arizona • Little Rock, Arkansas + 35 more

Conditions: HIV Infections
Interventions: APRETUDE, Cabotegravir tablet; Drug
Lead sponsor: ViiV Healthcare; Industry
Eligibility: 18 Years and older · Female only
Enrollment: 370 participants
Healthy volunteers: Accepts healthy volunteers
Timeline: 2022 – 2025
U.S. locations: 22
States / cities: Washington D.C., District of Columbia • Miami, Florida • Orlando, Florida + 13 more

Conditions: HIV Infections
Interventions: Standard of Care (SOC) Oral ART, Oral RPV, Oral CAB, RPV-LA Loading Dose, CAB-LA Loading Dose, RPV-LA Maintenance Dose, CAB-LA Maintenance Dose; Drug
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID); NIH
Eligibility: 18 Years and older
Enrollment: 456 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2019 – 2026
U.S. locations: 32
States / cities: Birmingham, Alabama • Los Angeles, California • San Diego, California + 24 more

Conditions: HIV Infections
Interventions: APRETUDE, Cabotegravir OLI; Drug
Lead sponsor: ViiV Healthcare; Industry
Eligibility: 18 Years and older · Male only
Enrollment: 287 participants
Healthy volunteers: Accepts healthy volunteers
Timeline: 2022 – 2024
U.S. locations: 17
States / cities: Los Angeles, California • San Francisco, California • Washington D.C., District of Columbia + 14 more

Conditions: HIV Infections
Interventions: Lenacapavir, Lenacapavir Tablet, Teropavimab, Zinlirvimab, Cabotegravir, Rilpivirine; Drug
Lead sponsor: Gilead Sciences; Industry
Eligibility: 18 Years and older
Enrollment: 590 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2026 – 2033
U.S. locations: 16
States / cities: San Francisco, California • DeLand, Florida • Fort Lauderdale, Florida + 12 more

Conditions: Infections, Human Immunodeficiency Virus and Hepatitis
Interventions: GSK1265744 Na Salt Tablets, GSK1265744 Free Acid Nanomilled Capsules, GSK1265744 Free Acid Micronized Capsules; Drug
Lead sponsor: ViiV Healthcare; Industry
Eligibility: 18 Years to 64 Years
Enrollment: 18 participants
Healthy volunteers: Accepts healthy volunteers
Timeline: 2012
U.S. locations: 1
States / cities: Overland Park, Kansas

Conditions: Infection, Human Immunodeficiency Virus, HIV Infections
Interventions: GSK1265744 30 mg; Drug
Lead sponsor: ViiV Healthcare; Industry
Eligibility: 18 Years to 70 Years
Enrollment: 16 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2015 – 2016
U.S. locations: 2
States / cities: Lakewood, Colorado • Minneapolis, Minnesota

Conditions: Infection, Human Immunodeficiency Virus, HIV Infections
Interventions: Cabotegravir (CAB) tablet, Rilpivirine (RPV) tablet, Cabotegravir - Injectable Suspension (CAB LA), Rilpivirine - Injectable Suspension (RPV LA), 2 NRTIs plus an INI, NNRTI, or PI; Drug
Lead sponsor: ViiV Healthcare; Industry
Eligibility: 18 Years and older
Enrollment: 618 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2016 – 2029
U.S. locations: 36
States / cities: Birmingham, Alabama • Phoenix, Arizona • Bakersfield, California + 28 more

Conditions: Infection, Human Immunodeficiency Virus
Interventions: GSK1265744 30 mg oral, Midazolam 3 mg oral + GSK1265744 30mg oral, GSK1265744 400 mg (200 nm), GSK1265744 400 mg (1 micro m), GSK1265744 400 mg (5 micro m); Drug
Lead sponsor: ViiV Healthcare; Industry
Eligibility: 18 Years to 65 Years
Enrollment: 43 participants
Healthy volunteers: Accepts healthy volunteers
Timeline: 2013 – 2014
U.S. locations: 1
States / cities: Overland Park, Kansas

Conditions: HIV Infections
Interventions: Cabotegravir Tablets, Rilpivirine Tablets, Cabotegravir Injectable Suspension, Rilpivirine Injectable Suspension; Drug
Lead sponsor: ViiV Healthcare; Industry
Eligibility: 18 Years and older
Enrollment: 1,049 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2017 – 2029
U.S. locations: 43
States / cities: Birmingham, Alabama • Phoenix, Arizona • Bakersfield, California + 33 more

Conditions: HIV Infections
Interventions: DTG/3TC, Cabotegravir (CAB) LA, Rilpivirine (RPV) LA; Drug
Lead sponsor: ViiV Healthcare; Industry
Eligibility: 18 Years and older
Enrollment: 171 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2023 – 2026
U.S. locations: 15
States / cities: Birmingham, Alabama • Bakersfield, California • Fort Lauderdale, Florida + 12 more

Conditions: Infection, Human Immunodeficiency Virus, HIV Infections
Interventions: CAB Oral Tablets, CAB LA, ABC/3TC Oral tablets, RPV Oral Tablets, HAART, RPV; Drug · Other
Lead sponsor: ViiV Healthcare; Industry
Eligibility: 18 Years and older
Enrollment: 309 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2014 – 2023
U.S. locations: 15
States / cities: Birmingham, Alabama • Bakersfield, California • Beverly Hills, California + 12 more

Conditions: HIV-1-infection
Interventions: Bictegravir, Lenacapavir, BIC/LEN FDC, Stable Baseline Regimen; Drug
Lead sponsor: Gilead Sciences; Industry
Eligibility: 18 Years and older
Enrollment: 689 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2022 – 2028
U.S. locations: 40
States / cities: Berkeley, California • Beverly Hills, California • Los Angeles, California + 34 more

Conditions: Infection, Human Immunodeficiency Virus
Interventions: Cabotegravir 30 mg current formulation, Cabotegravir 30 mg micronized new formulation 500 M, Cabotegravir 30 mg unmicronized new formulation 500 U, Cabotegravir 30 mg micronized new formulation 650 M, Cabotegravir 30 mg unmicronized new formulation 650 U; Drug
Lead sponsor: ViiV Healthcare; Industry
Eligibility: 18 Years to 65 Years
Enrollment: 37 participants
Healthy volunteers: Accepts healthy volunteers
Timeline: 2015
U.S. locations: 1
States / cities: Overland Park, Kansas

Conditions: Infection, Human Immunodeficiency Virus
Interventions: CAB, RIF; Drug
Lead sponsor: ViiV Healthcare; Industry
Eligibility: 18 Years to 65 Years
Enrollment: 15 participants
Healthy volunteers: Accepts healthy volunteers
Timeline: 2015
U.S. locations: 1
States / cities: Overland Park, Kansas

Conditions: HIV Infections
Interventions: GSK1265744 Tablets, Injectable GSK1265744, Placebo for GSK1265744 Tablets, Injectable Placebo for GSK1265744; Drug
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID); NIH
Eligibility: 18 Years to 65 Years
Enrollment: 199 participants
Healthy volunteers: Accepts healthy volunteers
Timeline: 2015 – 2018
U.S. locations: 4
States / cities: Los Angeles, California • San Francisco, California • Washington D.C., District of Columbia + 1 more

Conditions: HIV-1-infection
Interventions: Once daily CAB tablet + RPV tablet, Long acting CAB injectable + long acting RPV injectable; Drug
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID); NIH
Eligibility: 2 Years to 11 Years
Enrollment: 90 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2024 – 2029
U.S. locations: 2
States / cities: Atlanta, Georgia • Memphis, Tennessee

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Long-Acting Cabotegravir Plus VRC-HIVMAB075-00-AB (VRC07-523LS) for Viral Suppression in Adults Living With HIV-1

Safety, Tolerability and Acceptability of Long-Acting Cabotegravir (CAB LA) for the Prevention of HIV Among Adolescent Males

Injectable Cabotegravir Compared to TDF/FTC For PrEP in HIV-Uninfected Men and Transgender Women Who Have Sex With Men

A Study to Assess The Relative Bioavailability of New Tablet Formulations of GSK1265744 in Healthy Adult Subjects

An Study to Investigate the Recovery, Excretion, and Pharmacokinetics of 14C-GSK1265744 Administered as a Single Oral Dose and a Study to Describe the Pharmacokinetics of a Supratherapeutic Dose of GSK1265744 in Healthy Adult Subjects

Study to Evaluate Pharmacokinetic (PK), Safety and Tolerability of Cabotegravir (CAB) 400 Milligrams Per Milliliter (mg/mL) Formulation in Healthy Adult Participants

Healthy Volunteer Study To Assess The Bioavailability of GSK1265744 When Administered Orally Either When Fasted or Following a Meal.

Dose Ranging Study of GSK1265744 Plus Nucleoside Reverse Transcriptase Inhibitors for Induction of Human Immunodeficiency Virus-1 (HIV-1) Virologic Suppression Followed by Virologic Suppression Maintenance by GSK1265744 Plus Rilpivirine

A Study Evaluating Implementation Strategies for the Delivery of APRETUDE for Black cis-and Transgender Women in United States EHE Territories

The LATITUDE Study: Long-Acting Therapy to Improve Treatment SUccess in Daily LifE

A Study Evaluating Implementation Strategies for the Delivery of Cabotegravir in Low and High-Volume PrEP Site in the United States

Study of Lenacapavir, Teropavimab, and Zinlirvimab Versus Cabotegravir and Rilpivirine in Virologically Suppressed Adults With HIV-1 on Oral Daily Antiretroviral Therapy

Relative Bioavailability Study of GSK1265744 Formulations

Pharmacokinetics Study of GSK1265744 in Subjects With Severe Renal Impairment

Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine From Current Antiretroviral Regimen in Virologically Suppressed HIV-1-infected Adults

A Randomized Study to Assess the Relative Bioavailability of New Formulations of GSK1265744 Long Acting Parental (LAP) in Healthy Adult Subjects

Efficacy, Safety and Tolerability Study of Long-acting Cabotegravir Plus Long-acting Rilpivirine (CAB LA + RPV LA) in Human-immunodeficiency Virus-1 (HIV-1) Infected Adults

A Study to Evaluate the Efficacy, Safety, Participant Choice and Preference of an Oral Once-daily Regimen or a Long-acting Injectable Regimen Every Two Months for Treatment of Human Immunodeficiency Virus (HIV-1) in Adults Who Have Not Previously Taken Antiretroviral Therapy

A Phase IIb Study to Evaluate a Long-Acting Intramuscular Regimen for Maintenance of Virologic Suppression (Following Induction With an Oral Regimen of GSK1265744 and Abacavir/Lamivudine) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected, Antiretroviral Therapy-Naive Adult Subjects

Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen

Relative Bioavailability Study of Phase III Tablet Formulation of Cabotegravir

Effect of Rifampin (RIF) on the Pharmacokinetics (PK) of Oral Cabotegravir (CAB) in Healthy Subjects

Evaluating the Safety, Tolerability, and Pharmacokinetics of an Investigational, Injectable HIV Medicine (GSK1265744) in HIV-Uninfected Adults

Study of Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in Virologically Suppressed Children Living With HIV-1, Two to Less Than 12 Years of Age