HIV

A Randomized Phase 1 Study Evaluating Pharmacokinetics, Safety, and Tolerability of a High-Concentration, Long-Acting Cabotegravir Formulation in Adults Without HIV

Date: 
7/21/25
Citation: 

Han K, Benn P, Sievers J, Dorey D, Warwick-Sanders M, Hareedy R, Harkness L, Leemereise C, Offenbecker K, Donatti C, Brimhall DB, Schwabe C, Boyle C, Hassman MA, Knowles S, D'Amico R, Spreen WR. A Randomized Phase 1 Study Evaluating Pharmacokinetics, Safety, and Tolerability of a High-Concentration, Long-Acting Cabotegravir Formulation in Adults Without HIV. Clin Pharmacol Drug Dev. 2025 Jul;14(7):528-541. doi: 10.1002/cpdd.1538. Epub 2025 Apr 29. PMID: 40296638; PMCID: PMC12209996.

Long-acting (LA) cabotegravir 200-mg/mL (CAB200) injections are approved for HIV-1 prevention and as a complete LA HIV-1 treatment regimen with rilpivirine. A high-concentration suspension formulation, cabotegravir 400 mg/mL (CAB400-D), was developed to enable less frequent dosing and self-administration.

Health Topics: 
HIV

    Advancing Translation of Long-Acting Strategies for HIV and HIV-Associated Co-infections (AT LASt) (R61/R33 Clinical Trial Not Allowed)

    Grant Source: 
    NIH/NIAID

    In 2023, an estimated 39.9 million people globally were living with HIV, there were 1.3 million people who acquired HIV, and 630,000 people died from AIDS-related illnesses worldwide (World Health Organization [WHO]). Among people living with HIV (PLWH), morbidity and mortality is increasingly driven by co-infections. The risk of tuberculosis (TB) progressing from latent to active disease is estimated to be up to 20 times greater in PLWH than among those without HIV, with fatality rates of 16-35%. For HIV-associated hepatitis, WHO estimates that 2.6 million PLWH are also living with Hepatitis B Virus (HBV) and 2.75 million are also living with Hepatitis C Virus (HCV) worldwide.

    Health Topics: 
    HIV

      Request Funding to Explore Controlled Release of HIV Vaccines

      Grant Source: 
      NIH/NIAID

      NIAID’s new notice of funding opportunity (NOFO) Strategies for Controlled Release of HIV Vaccines (SCORE-H) (R01, Clinical Trial Not Allowed) supports research to advance controlled-release strategies for HIV vaccines that aim to elicit protective and durable broadly neutralizing responses and antiviral T-cell/innate responses.

      Health Topics: 
      HIV

        Evaluating Islatravir Administered Via Microneedle Array Patch for Long-Acting HIV Pre-exposure Prophylaxis Using Physiologically Based Pharmacokinetic Modelling

        Date: 
        10/27/22
        Citation: 

        Kinvig H, Cottura N, Lloyd A, Frivold C, Mistilis J, Jarrahian C, Siccardi M. Evaluating Islatravir Administered Via Microneedle Array Patch for Long-Acting HIV Pre-exposure Prophylaxis Using Physiologically Based Pharmacokinetic Modelling. Eur J Drug Metab Pharmacokinet. 2022 Sep 30. doi: 10.1007/s13318-022-00793-6. Epub ahead of print. PMID: 36178586.

        Technologies for long-acting administration of antiretrovirals (ARVs) for the prevention and treatment of HIV are at the forefront of research initiatives aiming to tackle issues surrounding drug adherence with the current standard of once-daily oral administration. Islatravir (ISL) is an emerging ARV that shows promising characteristics for long-acting prevention and treatment both orally as well as through alternative routes of administration.

        Health Topics: 
        HIV

          Cabotegravir Extended-Release Injectable Suspension: A Review in HIV-1 Pre-Exposure Prophylaxis

          Date: 
          10/27/22
          Citation: 

          Blair HA. Cabotegravir Extended-Release Injectable Suspension: A Review in HIV-1 Pre-Exposure Prophylaxis. Drugs. 2022 Oct 18. doi: 10.1007/s40265-022-01791-3. Epub ahead of print. PMID: 36255686.

          Cabotegravir extended-release (ER) injectable suspension (Apretude™) is the first long-acting injectable option to be approved for HIV-1 pre-exposure prophylaxis (PrEP). As an HIV-1 integrase strand transfer inhibitor, cabotegravir ER injectable suspension prevents DNA integration and inhibits HIV-1 replication.

          Health Topics: 
          HIV

            Long-Acting Injectable Human Immunodeficiency Virus Pre-Exposure Prophylaxis Preferred Over Other Modalities Among People Who Inject Drugs: Findings from a Qualitative Study in California

            Date: 
            8/12/22
            Citation: 

            Bazzi AR, Valasek CJ, Streuli SA, Vera CF, Harvey-Vera A, Philbin MM, Biello KB, Roth AM, Strathdee SA, Pines HA. Long-Acting Injectable Human Immunodeficiency Virus Pre-Exposure Prophylaxis Preferred Over Other Modalities Among People Who Inject Drugs: Findings from a Qualitative Study in California. AIDS Patient Care STDS. 2022 Jul;36(7):254-262. doi: 10.1089/apc.2022.0068. Epub 2022 Jun 21. PMID: 35727647.

            People who inject drugs (PWID) have extraordinarily low uptake of human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP) despite high levels of need. Long-acting PrEP modalities hold promise for HIV prevention among PWID, but product preferences remain poorly understood.

            Health Topics: 
            HIV

              Key population perceptions and opinions about long-acting antiretrovirals for prevention and treatment: a scoping review

              Date: 
              4/18/22
              Citation: 

              Sued O, Nardi N, Spadaccini L. Key population perceptions and opinions about long-acting antiretrovirals for prevention and treatment: a scoping review. Curr Opin HIV AIDS. 2022 Apr 18. doi: 10.1097/COH.0000000000000734. Epub ahead of print. PMID: 35438662.

              The objective of the current review is to update the perceptions of key populations and PLWH about LA, based on their opinion, acceptability, and willingness to use it.

              Health Topics: 
              HIV
              Pre-exposure Prophylaxis (PrEP)

                Resources Access for Preclinical Integrated Drug Development (RAPIDD) Program (X01 Clinical Trial Not Allowed)

                Grant Source: 
                NIH/NIAID

                The purpose of this FOA is to provide investigators working on the development of novel therapeutic products for HIV and HIV-associated co-infections (hepatitis B virus, hepatitis C virus, and Mycobacterium tuberculosis) with a mechanism to request NIAID DAIDS preclinical services to fill gaps in their product development efforts and facilitate the advancement of promising therapeutics from bench to clinics.

                Health Topics: 
                HIV
                Viral Hepatitis

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