Injectable HIV Treatment for Women

Overseen By Jaimie P Meyer, MD, MS, FACP

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Yale University

Must be taking: Oral ART

Disqualifiers: Pregnant, Breast-feeding, CAB/RPV resistance, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 12 months

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new injectable treatment for women with HIV. It examines how a pharmacist-led program can assist women in transitioning from daily pills to long-acting injections, using telehealth (phone or video visits) to support those with health-related social needs such as housing or food insecurity. Women who have successfully taken HIV medications for six months and face challenges like homelessness or recent substance use may be suitable candidates. As a Phase 2 trial, it measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important research.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications. However, since participants must be on oral ART (antiretroviral therapy) and virally suppressed, it seems likely you will continue your current HIV treatment until switching to the injectable form.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that cabotegravir and rilpivirine, when used together as an injectable treatment, have been studied in people with HIV. In a study involving 1,182 participants whose HIV was under control, researchers assessed the safety of this treatment over 48 weeks. Some serious side effects, such as allergic reactions and liver problems, were noted. Depression and other injection-related reactions were also reported. However, not everyone experienced these effects.

The FDA has already approved this treatment for HIV, indicating some confidence in its safety. However, individual reactions to medications can vary. Those with concerns should consult a healthcare professional for advice tailored to their health needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the injectable HIV treatment using Cabotegravir/Rilpivirine for women because it offers a new delivery method compared to the usual daily oral pills like tenofovir or efavirenz-based regimens. This treatment is administered as a long-acting injection, which means it can be given less frequently, potentially every two months, reducing the burden of taking daily medication and improving adherence. Additionally, Cabotegravir/Rilpivirine targets the HIV virus in a way that might offer more consistent blood levels of the drug, which is crucial for maintaining viral suppression and reducing the risk of drug resistance. This innovative approach could significantly improve the quality of life for women living with HIV.

What evidence suggests that this injectable HIV treatment could be effective for women?

Research has shown that combining cabotegravir and rilpivirine effectively treats HIV. Real-world studies indicate that this injectable treatment maintains the virus at very low levels in the body. Specifically, data shows that about 89% of people new to treatment achieved viral control with these injections. Participants in this trial can switch from oral to injectable therapy, guided by a clinic-based pharmacist via telehealth. The long-lasting nature of this therapy reduces the need for daily pills, which is a major benefit. This method has proven effective and generally easy to tolerate, offering a promising alternative to daily medication. ^{6 7 8 9 10}

Who Is on the Research Team?

Jaimie Meyer, MD, MS, FACP

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for women living with HIV who have health-related social needs. It's designed to see how well they do when a pharmacist helps manage their treatment, which includes long-acting injectable drugs. The study will also use telehealth to reach participants.

Inclusion Criteria

Receiving HIV care-related services from Yale New Haven Health (YNHH)

Living with diagnosed HIV

Have experienced at least one HRSN: a) homelessness or housing insecurity; b) food insecurity; c) criminal legal system involvement; OR d) substance use in the past 6 months (from self-report at screening)

Exclusion Criteria

I am able to understand and willing to sign the informed consent myself.

I cannot take CAB/RPV LA due to health reasons.

Pregnant or breast-feeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Introductory Telehealth Visit

Participants meet with a clinic-based pharmacist via telehealth to discuss CAB/RPV LA and possible switch from oral to injectable therapy

1 visit

1 telehealth visit (phone or video)

Treatment

Participants receive CAB/RPV LA injections and engage with the CDTM+ intervention

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cabotegravir/Rilpivirine

Trial Overview The intervention being tested is a pharmacist-led model where the medication management for HIV treatment involves long-acting injections of Cabotegravir/Rilpivirine. This approach will be assessed for its effectiveness and implementation through both in-person and telehealth services.

How Is the Trial Designed?

Group I: Pharmacist lead CDTM+ Experimental Treatment 2 Interventions

Participants will meet with a clinic-based pharmacist via telehealth for an introductory visit to discuss CAB/RPV LA and possible switch from oral to injectable therapy. The tele-visit can occur by phone or video visit.

Cabotegravir/Rilpivirine is already approved in United States, European Union for the following indications:

Approved in United States as Cabenuva for:

• Human immunodeficiency virus type 1 (HIV-1) infection in adults to replace a current antiretroviral regimen in those who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure

Approved in European Union as Vocabria and Rekambys for:

• Maintenance treatment of adults who have undetectable HIV levels in the blood (viral load less than 50 copies/mL) with their current antiretroviral treatment, and when the virus has not developed resistance to non-nucleoside reverse transcriptase inhibitors (NNRTIs) and integrase strand transfer inhibitors

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

ViiV Healthcare

Industry Sponsor

Trials

379

Recruited

479,000+

Founded

2009

Headquarters

London, England, UK

Known For

HIV Research

Top Products

- Tivicay (dolutegravir), - Triumeq (abacavir/dolutegravir/lamivudine), - Juluca (dolutegravir/rilpivirine), - Apretude (cabotegravir)

Dr. Harmony Garges

ViiV Healthcare

Chief Medical Officer

MD

Deborah Waterhouse

ViiV Healthcare

Chief Executive Officer since 2017

Bachelor's degree in Business Administration

Published Research Related to This Trial

Cabotegravir and rilpivirine, as long-acting injectable therapy for HIV-1, have shown to be non-inferior to traditional oral triple-therapy in phase II and III trials, indicating their effectiveness as a treatment option.

Patients generally accept the 4-weekly or 8-weekly injections despite some experiencing injection-site reactions, but there are still important questions regarding missed doses, drug interactions, and the therapy's efficacy across different HIV-1 subtypes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating cabotegravir/rilpivirine long-acting, injectable in the treatment of HIV infection: emerging data and therapeutic potential. Fernandez, C., van Halsema, CL.[2020]

Cabotegravir/rilpivirine (CAB/RPV) is the first complete injectable antiretroviral therapy approved for HIV treatment, offering a monthly intramuscular injection option that improves adherence compared to daily oral medications.

Clinical trials have shown CAB/RPV to achieve high rates of sustained viral suppression with a favorable safety profile, while also enhancing patient satisfaction due to its convenience and confidentiality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic review of cabotegravir/rilpivirine long-acting antiretroviral injectable and implementation considerations at an HIV specialty clinic. Howe, ZW., Norman, S., Lueken, AF., et al.[2022]

Cabenuva is the first complete injectable therapy for adults with HIV-1, combining cabotegravir and rilpivirine, and is administered once a month after an initial month of oral treatment.

This innovative treatment offers a new option for HIV management, potentially improving adherence and convenience for patients compared to daily oral medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First Extended-Release Injectable Drug Therapy for HIV. Aschenbrenner, DS.[2023]

Cabotegravir (CAB) combined with rilpivirine (RPV) is the first long-acting dual therapy approved for HIV-1 treatment, showing comparable maintenance of viral suppression over 160 weeks with low rates of virological failure.

This regimen offers a convenient alternative to daily oral therapy, as it is administered via intramuscular injections every 4 weeks, with minimal adverse effects and no negative impact on renal or bone health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cabotegravir-Rilpivirine: The First Complete Long-Acting Injectable Regimen for the Treatment of HIV-1 Infection. Durham, SH., Chahine, EB.[2022]

Cabenuva (cabotegravir/rilpivirine) is a long-acting injectable treatment for HIV that has shown equal effectiveness to traditional oral antiretroviral therapy in maintaining HIV-1 suppression, based on major clinical trials like ATLAS and FLAIR.

The ATLAS-2 M study demonstrated that administering Cabenuva every 8 weeks is just as effective as every 4 weeks, which can improve patient adherence and reduce the stigma associated with frequent treatment, while also minimizing risks of treatment-related toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cabotegravir/Rilpivirine: the last FDA-approved drug to treat HIV. Taki, E., Soleimani, F., Asadi, A., et al.[2022]

In a study of 1,752 HIV-positive patients, 31.2% were found ineligible for the injectable treatment of cabotegravir and rilpivirine due to factors like detectable viral load and history of virological failures.

The proportion of ineligible patients increased to 47.3% when considering those with complete resistance test data, highlighting significant barriers to the feasibility of this treatment strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are we ready for long-acting? A feasibility evaluation of long-acting cabotegravir-rilpivirine in clinical practice. Borghetti, A., Farinacci, D., Ciccullo, A., et al.[2022]

Long-acting injectable therapies, cabotegravir (CAB) and rilpivirine (RPV), have been shown to be as effective as traditional oral antiretroviral therapy (ART) for HIV-1, maintaining efficacy over 96 weeks in clinical trials with virologically suppressed adults.

CAB has also demonstrated effectiveness as a preexposure prophylaxis (PrEP) option, significantly reducing HIV infections compared to daily oral medication, indicating its potential for broader use in HIV prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new paradigm for antiretroviral delivery: long-acting cabotegravir and rilpivirine for the treatment and prevention of HIV. Bares, SH., Scarsi, KK.[2023]

Long-acting injectable cabotegravir-rilpivirine (CAB-RPV) significantly improves viral suppression rates in people with HIV who have adherence challenges, achieving 60% suppression at 3 months compared to only 13% with standard oral treatment.

In a model projecting outcomes over 3 years, CAB-RPV combined with supportive services is expected to lead to a 44% viral suppression rate and a life expectancy of 9.4 years, outperforming both standard oral treatments and those with additional support services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Projected Benefits of Long-Acting Antiretroviral Therapy in Nonsuppressed People With Human Immunodeficiency Virus Experiencing Adherence Barriers. Chen, W., Gandhi, M., Sax, PE., et al.[2023]

Citations

1. viivhealthcare.com viivhealthcare.com/hiv-news-and-media/news/press-releases/2025/july/daily-pills-after-achieving-rapid-viral-suppression/

ViiV Healthcare data show 89% of treatment-naïve people ... Multiple real-world studies show consistent high effectiveness of Vocabria + Rekambys (cabotegravir + rilpivirine LA (CAB+RPV LA)) across a ...

2. gsk.com gsk.com/en-gb/media/press-releases/viiv-healthcare-presents-new-data-demonstrating-positive-real-world-impact-of-its-innovative-long-acting-injectables-for-hiv-at-ias-2025/

ViiV Healthcare presents new data demonstrating positive ... Real-world and implementation data describe effectiveness of long-acting Vocabria + Rekambys (CAB+RPV LA) for HIV treatment.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40794804/

Long-acting cabotegravir and rilpivirine for the treatment of ... This narrative review aims to (i) evaluate the effectiveness and safety of LAI CAB + RPV in real-world clinical practice; (ii) assess outcomes ...

4. academic.oup.com academic.oup.com/jac/article/80/8/2169/8164438

Effectiveness and predictors of treatment discontinuation of ... Phase 3 studies have shown long-acting (LA) cabotegravir/rilpivirine to be effective and tolerable as maintenance therapy in people with HIV ( ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12356711/

Long-Acting Injectable Antiretroviral Drugs for Pregnant ... Two-monthly injectable cabotegravir significantly reduced HIV risk compared to daily oral PrEP. Among men, HIV incidence was 0.41 vs. 1.22 per ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2021/212888s000lbl.pdf

Cabenuva - accessdata.fda.gov The safety assessment of CABENUVA is based on the analysis of pooled 48-week data from 1,182 virologically suppressed subjects with HIV-1 infection in 2 ...

7. cabenuva.com cabenuva.com/

Long-Acting HIV Treatment | CABENUVA (cabotegravir ... ANNOUNCER: Serious side effects include allergic reactions, post-injection reactions, liver problems, and depression. If you have a rash and other allergic ...

8. clinicalinfo.hiv.gov clinicalinfo.hiv.gov/en/guidelines/perinatal/safety-toxicity-arv-agents-integrase-inhibitors-cabotegravir-vocabria

Appendix B: Cabotegravir - Safety and Toxicity in Pregnancy No other prospective PK data on LA CAB/RPV for HIV treatment during pregnancy and postpartum exists. Earlier clinical trial PK data are limited to pregnant ...

9. viivhealthcare.com viivhealthcare.com/en-us/media-center/news/press-releases/2021/march/viiv-healthcare-presents-data-for-long-acting-cabotegravir-and-rilpivirine/

ViiV Healthcare presents data for long-acting cabotegravir ... Long-term efficacy and safety data from the phase IIIb ATLAS-2M study reinforce the therapeutic potential of long-acting cabotegravir and rilpivirine.

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11650856/

Long-Acting Injectable Cabotegravir and Rilpivirine in a ... Bimonthly long-acting injectable CAB/RPV may not be suitable for pregnant women, and monitoring of exposed infants is warranted. Keywords: HIV, pregnancy, long- ...