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Withdrawn Phase 2 Interventional Accepts healthy volunteers

Combined Injectable Treatment for HIV and OUD

NCT05991622
Conditions
Human Immunodeficiency Virus, Opioid Use Disorder
Interventions
Combined LAI Treatment: Cabenuva and Sublocade
Drug
Lead sponsor
Rhode Island Hospital
Other
Eligibility
18 Years to 65 Years
Healthy volunteers
Accepts healthy volunteers
Timeline
2022 – 2026
U.S. locations
1
States / cities
Providence, Rhode Island
Conditions
HIV Infections
Interventions
Cabotegravir (CAB) tablet, Rilpivirine (RPV) tablet, Cabotegravir - Injectable Suspension (CAB LA), Rilpivirine - Injectable Suspension (RPV LA), ABC/DTG/3TC STR - Tablet, DTG Tablet
Drug
Lead sponsor
ViiV Healthcare
Industry
Eligibility
18 Years and older
Enrollment
631 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2029
U.S. locations
25
States / cities
Birmingham, Alabama • Bakersfield, California • Long Beach, California + 21 more
Conditions
Healthy Subject
Interventions
SACT-1, EDURANT 25Mg Tablet
Drug
Lead sponsor
Aptorum International Limited
Industry
Eligibility
18 Years and older
Enrollment
16 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2021
U.S. locations
1
States / cities
Fargo, North Dakota
Conditions
HIV-1 Infection
Interventions
E/C/F/TAF
Drug
Lead sponsor
Gilead Sciences
Industry
Eligibility
18 Years and older
Enrollment
66 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2019
U.S. locations
3
States / cities
Ft. Pierce, Florida • Orlando, Florida • West Palm Beach, Florida
Conditions
Human Immunodeficiency Virus Type 1 (HIV-1)
Interventions
Cabotegravir Injectable Suspension, Rilpivirine Injectable Suspension
Drug
Lead sponsor
ViiV Healthcare
Industry
Eligibility
18 Years and older
Enrollment
118 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2022
U.S. locations
10
States / cities
Bakersfield, California • Fort Lauderdale, Florida • Ft. Pierce, Florida + 7 more
Conditions
HIV-DDI
Interventions
Riociguat (Adempas, BAY 63-2521), ATRIPLA, COMPLERA, STRIBILD, TRIUMEQ, Antiretroviral protease inhibitor
Drug
Lead sponsor
Bayer
Industry
Eligibility
18 Years to 65 Years
Enrollment
40 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016
U.S. locations
2
States / cities
Orlando, Florida • Boston, Massachusetts
Conditions
HIV-1 Infection
Interventions
Sirolimus
Drug
Lead sponsor
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Network
Eligibility
18 Years and older
Enrollment
32 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2018
U.S. locations
10
States / cities
San Francisco, California • Washington D.C., District of Columbia • Miami, Florida + 7 more
Conditions
HIV Infections
Interventions
Oral Cabotegravir (CAB), Oral Rilpivirine (RPV), Long-Acting Injectable Cabotegravir (CAB LA), Long-Acting Injectable Rilpivirine (RPV LA), Combination Antiretroviral Therapy (cART)
Drug
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eligibility
12 Years to 17 Years
Enrollment
168 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2025
U.S. locations
8
States / cities
Los Angeles, California • Aurora, Colorado • Miami, Florida + 5 more
Conditions
HIV Infections
Interventions
DTG 50 mg, RPV 25 mg, CAR
Drug
Lead sponsor
ViiV Healthcare
Industry
Eligibility
18 Years and older
Enrollment
518 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2023
U.S. locations
13
States / cities
Bakersfield, California • Washington D.C., District of Columbia • Fort Lauderdale, Florida + 9 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
Interventions
rilpivirine/cabotegravir
Drug
Lead sponsor
Whitman-Walker Institute
Government
Eligibility
18 Years and older
Enrollment
180 participants
Timeline
2023 – 2025
U.S. locations
2
States / cities
Washington D.C., District of Columbia
Conditions
HIV-1 Infection
Interventions
F/TAF, ABC/3TC, ABC/3TC Placebo, F/TAF Placebo, 3rd ARV agent
Drug
Lead sponsor
Gilead Sciences
Industry
Eligibility
18 Years and older
Enrollment
567 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2019
U.S. locations
34
States / cities
Phoenix, Arizona • Beverly Hills, California • La Jolla, California + 26 more
Conditions
HIV-1 Infection, HCV Infection
Interventions
E/C/F/TAF, F/R/TAF, LDV/SOF
Drug
Lead sponsor
Gilead Sciences
Industry
Eligibility
18 Years and older
Enrollment
150 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2017
U.S. locations
42
States / cities
Birmingham, Alabama • Phoenix, Arizona • Los Angeles, California + 32 more
Conditions
HIV-1 Infection
Interventions
FTC/TDF, F/TAF, Allowed third antiretroviral agent, FTC/TDF Placebo, F/TAF Placebo
Drug
Lead sponsor
Gilead Sciences
Industry
Eligibility
18 Years and older
Enrollment
668 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2019
U.S. locations
57
States / cities
Birmingham, Alabama • Phoenix, Arizona • Beverly Hills, California + 40 more
Conditions
HIV Infections
Interventions
CAB-RPV LA, Standard treatment within an HIV clinic
Other
Lead sponsor
Boston Medical Center
Other
Eligibility
18 Years and older
Enrollment
25 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2023
U.S. locations
2
States / cities
Boston, Massachusetts
Conditions
HIV-1 Infection
Interventions
Not listed
Lead sponsor
Prema Menezes, PhD, PA-C
Other
Eligibility
18 Years and older · Female only
Enrollment
33 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2015
U.S. locations
1
States / cities
Chapel Hill, North Carolina
Conditions
HIV-1 Infection
Interventions
E/C/F/TAF, ABC/3TC, Third Antiretroviral Agent
Drug
Lead sponsor
Gilead Sciences
Industry
Eligibility
18 Years and older
Enrollment
275 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2018
U.S. locations
12
States / cities
Phoenix, Arizona • Los Angeles, California • Washington D.C., District of Columbia + 8 more
Conditions
HIV-1 Infection
Interventions
FTC/RPV/TAF, FTC/RPV/TDF Placebo, FTC/RPV/TDF, FTC/RPV/TAF Placebo
Drug
Lead sponsor
Gilead Sciences
Industry
Eligibility
18 Years and older
Enrollment
632 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2019
U.S. locations
75
States / cities
Birmingham, Alabama • Phoenix, Arizona • Beverly Hills, California + 56 more
Conditions
HIV Infections, HIV-1, Human Immunodeficiency Virus Type 1
Interventions
TMC278, Efavirenz
Drug
Lead sponsor
Tibotec Pharmaceuticals, Ireland
Industry
Eligibility
18 Years to 99 Years
Enrollment
694 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2011
U.S. locations
32
States / cities
Birmingham, Alabama • Phoenix, Arizona • Beverly Hills, California + 29 more
Conditions
Healthy Participants
Interventions
Metformin, Rilpivirine
Drug
Lead sponsor
Janssen R&D Ireland
Industry
Eligibility
18 Years to 55 Years
Enrollment
20 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2012 – 2013
U.S. locations
1
States / cities
Overland Park, Kansas
Conditions
HIV Infections
Interventions
CABENUVA
Drug
Lead sponsor
ViiV Healthcare
Industry
Eligibility
18 Years and older
Enrollment
44 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2024
U.S. locations
15
States / cities
Evans, Georgia • East Lansing, Michigan • Novi, Michigan + 12 more
Conditions
HIV
Interventions
Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), Feasibility of Intervention Measure (FIM), HIV Stigma Scale Questionnaire, HIV Treatment Satisfaction Questionnaire status version (HIVTSQs12), HIV Treatment Satisfaction Questionnaire change version (HIVTSQc12), Needs and Barriers Assessment, Pre-visit Outreach, Qualitative interview - patient participants, Staff education, Staff Month 7 and 15 Survey - Staff Burden and Engagement, Qualitative interview - staff
Behavioral
Lead sponsor
University of Nebraska
Other
Eligibility
19 Years and older
Enrollment
75 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2028
U.S. locations
4
States / cities
Harlan, Iowa • Shenandoah, Iowa • Grand Island, Nebraska + 1 more
Conditions
HIV Infections
Interventions
CAB LA + RPV LA, Oral ART
Drug
Lead sponsor
ViiV Healthcare
Industry
Eligibility
12 Years and older
Enrollment
326 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2028
U.S. locations
39
States / cities
Birmingham, Alabama • Los Angeles, California • Aurora, Colorado + 29 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