Bictegravir-Tenofovir alafenamide-Emtricitabine Biktarvy
Darunavir-Cobicistat-Tenofovir alafenamide-Emtricitabine Symtuza
Dolutegravir-Abacavir-Lamivudine Triumeq
Dolutegravir-Lamivudine Dovato
Dolutegravir-Rilpivirine Juluca
Doravirine-Tenofovir DF-Lamivudine Delstrigo
Efavirenz-Tenofovir DF-Emtricitabine Atripla
Elvitegravir-Cobicistat-Tenofovir alafenamide-Emtricitabine Genvoya
Elvitegravir-Cobicistat-Tenofovir DF-Emtricitabine Stribild
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Rilpivirine-Tenofovir DF-Emtricitabine Complera
Enfuvirtide Fuzeon
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Didanosine Videx
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Tenofovir alafenamide-Emtricitabine Descovy
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Tenofovir DF-Emtricitabine Truvada and Multiple Generics
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Lopinavir-Ritonavir Kaletra
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Tipranavir Aptivus
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Cabotegravir (Apretude)
Other Names: Injectable cabotegravir, Long-acting injectable cabotegravirAll Clinical Trials
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Common TitleECLAIR Industry
Official Title A Phase IIa Study to Evaluate the Safety, Tolerability and Acceptability of Long Acting Injections of the HIV Integrase Inhibitor, GSK1265744, in HIV Uninfected Men (ECLAIR)
Phase Phase IIA
ClinicalTrials.gov NCT02076178
Treatments
Cabotegravir
Cabotegravir
Tradename:ApretudeOther Names:Injectable cabotegravir, Long-acting injectable cabotegravirClass:Integrase Inhibitors (INSTI)Categories PREP
Funding
IndustryViiV Healthcare
References
- Markowitz M, Frank I, Grant RM, et al. Safety and tolerability of long-acting cabotegravir injections in HIV-uninfected men (ECLAIR): a multicentre, double-blind, randomised, placebo-controlled, phase 2a trial. Lancet HIV. 2017;4:e331-e340.
Common TitleHPTN 077 Non-Industry
Official Title Evaluating the Safety, Tolerability, and Pharmacokinetics of an Investigational, Injectable HIV Medicine (GSK1265744[Cabotegravir]) in HIV-Uninfected Adults
Phase Phase IIA
ClinicalTrials.gov NCT02178800
Treatments
Cabotegravir
Cabotegravir
Tradename:ApretudeOther Names:Injectable cabotegravir, Long-acting injectable cabotegravirClass:Integrase Inhibitors (INSTI)Categories PREP
Funding
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)
References
- Landovitz RJ, Li S, Grinsztejn B, et al. Safety, tolerability, and pharmacokinetics of long-acting injectable cabotegravir in low-risk HIV-uninfected individuals: HPTN 077, a phase 2a randomized controlled trial. PLoS Med. 2018;15:e1002690.
- Landovitz RJ, Zangeneh SZ, Chau G, et al. Cabotegravir is not associated with weight gain in human immunodeficiency virus-uninfected individuals in HPTN 077. Clin Infect Dis. 2020;70:319-22.
Official Title A Phase 2b/3 Double Blind Safety and Efficacy Study of Injectable Cabotegravir Compared to Daily Oral Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC), For Pre-Exposure Prophylaxis in HIV-Uninfected Cisgender Men and Transgender Women Who Have Sex With Men
Purpose / DescriptionPhase IIb/III
Phase Phase III
ClinicalTrials.gov NCT02720094
Treatments
Cabotegravir
Cabotegravir
Tradename:ApretudeOther Names:Injectable cabotegravir, Long-acting injectable cabotegravirClass:Integrase Inhibitors (INSTI)Categories PREP
Funding
IndustryViiV Healthcare
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)
References
- Landovitz RJ, Donnell D, Clement ME, et al. Cabotegravir for HIV prevention in cisgender men and transgender women. N Engl J Med. 2021;385:595-608.
Common TitleHPTN 083-1 (Adolescents) Non-Industry Industry
Official Title Safety, Tolerability and Acceptability of Long-Acting Cabotegravir (CAB LA) for the Prevention of HIV Among Adolescent Males - A Sub-study of HPTN 083
Purpose / DescriptionThe purpose of this study is to establish the minimum safety, tolerability and acceptability data needed to support the use of cabotegravir long-acting injection (CAB LA) in an adolescent population, potentially transforming the field of HIV prevention for young people.
Phase Phase II
ClinicalTrials.gov NCT04692077
Treatments
Cabotegravir
Cabotegravir
Tradename:ApretudeOther Names:Injectable cabotegravir, Long-acting injectable cabotegravirClass:Integrase Inhibitors (INSTI)Funding
IndustryViiV Healthcare
Non-IndustryNational Institute of Allergy and Infectious Diseases
References
No references available for this clinical trial
Official Title A Phase 3 Double Blind Safety and Efficacy Study of Long-Acting Injectable Cabotegravir Compared to Daily Oral TDF/FTC for Pre-Exposure Prophylaxis in HIV-Uninfected Women
Phase Phase III
ClinicalTrials.gov NCT03164564
Treatments
Cabotegravir
Cabotegravir
Tradename:ApretudeOther Names:Injectable cabotegravir, Long-acting injectable cabotegravirClass:Integrase Inhibitors (INSTI)Categories PREP
Funding
IndustryViiV Healthcare
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID and Bill and Melinda Gates Foundation
References
- Delany-Moretlwe S, Hughes JP, Bock P, et al. Cabotegravir for the prevention of HIV-1 in women: results from HPTN 084, a phase 3, randomised clinical trial. Lancet. 2022;399:1779–89.
Common TitleHPTN 084-1 (Adolescents-LIFT Study) Non-Industry Industry
Official Title Safety, Tolerability and Acceptability of Long-Acting Cabotegravir (CAB LA) for the Prevention of HIV among Adolescent Females – A Sub-study of HPTN 084
Purpose / DescriptionTo establish the minimum safety, tolerability and acceptability data needed to support the use of cabotegravir long-acting injection (CAB LA) in an adolescent population, potentially transforming the field of HIV prevention for young people.
Phase Phase IIB
Treatments
Cabotegravir
Cabotegravir
Tradename:ApretudeOther Names:Injectable cabotegravir, Long-acting injectable cabotegravirClass:Integrase Inhibitors (INSTI)Funding
IndustryViiV Healthcare
Non-IndustryNational Institute of Allergy and Infectious Diseases
References
No references available for this clinical trial
Cabotegravir Slide Deck
October 6, 2023
Clinical Trial Image Decks
HPTN 083 - October 6, 2023
HPTN 084 (LIFE Study) - October 6, 2023