HIV Clinical Trial Monitor — Long-Acting ART, Cure Research & PrEP Pipeline Alerts 2026

The HIV clinical trial landscape in 2026

HIV medicine is undergoing its most consequential transformation since the introduction of combination antiretroviral therapy in the mid-1990s. For four decades, daily oral pills were the universal standard of HIV treatment and prevention. That is now changing. The approval of long-acting cabotegravir/rilpivirine (Cabenuva, ViiV Healthcare/Janssen) for treatment in 2021 and the dramatic results of the PURPOSE 1 and PURPOSE 2 trials with lenacapavir (Sunlenca, Gilead) — showing near-complete prevention of HIV acquisition with a twice-yearly injection — have validated a new paradigm: injectable therapy that removes the daily adherence burden entirely. The FDA approved lenacapavir-based PrEP in 2024, a landmark that has reorganized the competitive landscape and is driving a new generation of clinical trial registrations.

Simultaneously, the scientific community has never been closer to a functional HIV cure. The "shock-and-kill" hypothesis — reactivating the latent viral reservoir and then clearing it — has been refined through years of trials; "block-and-lock" strategies that permanently silence the reservoir are entering clinical evaluation. Broadly neutralizing antibodies (bnAbs) can suppress viremia in the absence of antiretroviral therapy in some patients and are being evaluated both as treatment and as components of cure strategies. CAR-T cell therapies re-engineered to target HIV-infected cells are in early Phase 1 trials. The pipeline has never been more mechanistically diverse.

The 32 recruiting trials in our database reflect the full breadth of this pipeline: from ViiV Healthcare and Gilead's head-to-head long-acting formulation programs to NIH/NIAID-funded cure research at Johns Hopkins, Yale, and the HIV Vaccine Trials Network. TB-HIV co-infection — particularly relevant for global health programs — is a distinct and active research domain. DataLookout tracks across all of these areas so no new registration goes unnoticed.

• Long-acting ART for treatment — cabotegravir/rilpivirine IM (Cabenuva, approved), lenacapavir SC (approved), islatravir combinations, VH4 (ViiV next-gen pipeline)
• Long-acting PrEP — injectable cabotegravir (Apretude, approved), lenacapavir (approved for PrEP 2024), broadly neutralizing antibodies as PrEP
• Broadly neutralizing antibodies (bnAbs) — VRC01, PGT121, N6LS, 3BNC117, 10-1074 (in combinations and as monotherapy for reservoir clearance)
• HIV cure strategies — shock-and-kill (TLR agonists, HDAC inhibitors as LRAs), block-and-lock (didehydro-cortistatin A analogs), therapeutic vaccines
• CAR-T cell therapy for HIV — CD4-based constructs, dual-targeting approaches
• TB-HIV co-infection — rifampicin-compatible regimens, shorter TB treatment in PLHIV, ACTG network trials
• HIV in special populations — pediatric long-acting formulations, HIV in aging/comorbidities, HIV-associated neurocognitive disorders

What we monitor for HIV

Our system pulls from the ClinicalTrials.gov API every day. For an HIV watch profile, you can configure alerts for:

• Keywords: "HIV," "HIV-1," "HIV infection," "antiretroviral," "ART," "PrEP," "pre-exposure prophylaxis," "long-acting," "broadly neutralizing antibody," "bnAb," "HIV cure," "latent reservoir," "lenacapavir," "cabotegravir," "islatravir," "CAR-T HIV"
• Phase filters: Phase 1 (novel mechanisms, cure strategies, first-in-human bnAbs), Phase 2 (proof-of-concept, combination bnAb studies), Phase 3 (pivotal long-acting ART/PrEP trials)
• Sponsor type: large pharma (ViiV Healthcare, Gilead, Janssen), academic/NIH networks (ACTG, HPTN, HVTN), global health funders (Gates Foundation-sponsored)
• Study status: not yet recruiting, recruiting, active not recruiting
• Sub-population: treatment-naive, virologically suppressed, pediatric/adolescent, pregnant women, TB co-infected, long-term non-progressors

The long-acting revolution in HIV — what the PURPOSE trials mean for the pipeline

The PURPOSE 1 and PURPOSE 2 trials for lenacapavir-based PrEP represent one of the most significant clinical results in HIV prevention since the original iPrEx trial established oral PrEP in 2010. PURPOSE 1, conducted in cisgender women in sub-Saharan Africa, showed zero infections in the lenacapavir arm — 100% efficacy — against a background incidence rate of approximately 2.4 per 100 person-years. PURPOSE 2, conducted in a diverse global population including men who have sex with men and transgender women, showed 96% efficacy compared to oral tenofovir/emtricitabine. Gilead received FDA approval for lenacapavir PrEP in 2024, making it the first injectable agent approved for HIV prevention.

The commercial and pipeline implications are substantial. ViiV Healthcare, whose injectable cabotegravir (Apretude) had been the leading long-acting PrEP option, faces direct competition. Both companies are now running trials exploring next-generation formulations — longer dosing intervals (annual or beyond), oral lead-in alternatives, and adolescent/pediatric data packages. The race toward annual or even longer-acting formulations will generate a steady cadence of new Phase 2 and Phase 3 registrations over the next three to five years.

For HIV cure research, the long-acting paradigm has also created a new opportunity: bnAb-based "analytical treatment interruption" trials — where long-acting antibodies are used to maintain viral suppression in the absence of ART — are now feasible as outpatient protocols in a way that daily-oral-dependent designs could not support. BD teams, investors, and global health researchers tracking the HIV space need daily visibility into this rapidly shifting pipeline to make informed decisions about partnering, licensing, and advocacy.

Who uses HIV trial monitoring

• Infectious disease pharma BD teams — tracking long-acting ART, PrEP, bnAb, and cure-strategy registrations from ViiV, Gilead, and emerging biotechs; monitoring Phase 3 transitions and new formulation programs
• Global health researchers and funders — monitoring ACTG, HPTN, and Gates-funded trials for TB-HIV, pediatric, and resource-limited settings programs
• HIV advocacy organizations — tracking access to long-acting therapies, inclusion of key populations (cisgender women, transgender individuals, PWID) in pivotal trials, and compassionate use programs
• CROs with infectious disease practices — identifying new sponsor relationships and site qualification opportunities for complex long-acting and cure-strategy protocols
• Academic infectious disease programs and KOLs — monitoring industry cure and bnAb programs for investigator-site participation, collaborative research, and publication opportunities

How DataLookout works

We run a direct API connection to ClinicalTrials.gov every morning, collecting all new and updated trials. Our matching engine compares each trial against your profile — condition keywords, drug targets, phase, sponsor type, and study status. Only relevant trials reach your inbox.

Your daily digest includes: trial title, phase, sponsor, current status, enrollment target, primary endpoint, and a direct link to the ClinicalTrials.gov record. No noise, no duplicate alerts.

Pricing

Free — $0 forever: 1 disease tracker, weekly digest, ClinicalTrials.gov monitoring. No credit card required.

Starter — $49/month: 5 disease/keyword profiles, daily digest, all phase and sponsor filters. Best for individual analysts.

Pro — $149/month: Unlimited profiles, daily digest, priority support. Best for BD and CI teams.