Cabotegravir for HIV Prevention

(ASCEND Trial)

Not yet recruiting at 1 trial location

Overseen By Suzanne McCluskey, MD, MSc

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Massachusetts General Hospital

Must not be taking: Carbamazepine, Rifampin, others

Disqualifiers: Pregnancy, HIV positive, 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

Compensation: Varies

Number of Visits: 7

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a long-acting injectable treatment called cabotegravir to prevent HIV in people who inject drugs and have related sexual risks. Researchers aim to evaluate the effectiveness of this treatment when combined with support services like transportation assistance and financial incentives. Suitable participants have injected non-prescription drugs within the last six months and have a negative HIV test. The trial seeks to determine if this approach is effective and practical for preventing HIV in high-risk groups. As a Phase 4 trial, cabotegravir is already FDA-approved and proven effective, and this research helps assess how the treatment benefits more patients.

Will I have to stop taking my current medications?

You may need to stop taking certain medications like Carbamazepine, Rifampin, Oxcarbazepine, Rifapentine, Phenobarbital, and Phenytoin to participate in this trial. If you are on any of these, you should discuss with the trial team about your options.

What is the safety track record for cabotegravir?

Research has shown that cabotegravir, a long-acting injection for preventing HIV, is generally well-tolerated. In studies involving over 2,000 people, few discontinued the treatment due to side effects. Most participants experienced reactions at the injection site, such as pain or swelling, but these were common and usually mild. Cabotegravir has also proven safe and highly effective in reducing the risk of HIV infection. Overall, the safety results are encouraging for those considering joining a trial. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Cabotegravir is unique because it offers a long-acting injectable option for HIV prevention, setting it apart from the daily oral pills like Truvada and Descovy that are currently standard. Researchers are excited because this injectable form is administered only once every two months, which can greatly improve adherence and convenience compared to daily pills. Additionally, cabotegravir targets HIV integration into the host DNA, a crucial step in the virus's replication process, offering a new mechanism of action that enhances its preventive effectiveness.

What is the effectiveness track record for cabotegravir in preventing HIV?

Research has shown that cabotegravir is highly effective at preventing HIV, with over 99% effectiveness in real-world use. This long-lasting injection is safe and generally well-tolerated, with few side effects. Studies have demonstrated that cabotegravir outperformed some daily HIV prevention pills. Overall, cabotegravir is a proven and promising option for preventing HIV. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults who use non-prescription injectable drugs and are at risk of getting HIV, possibly through sexual activities. The study aims to see if giving them long-acting cabotegravir injections and support services helps prevent HIV.

Inclusion Criteria

HIV Ab/Ag test (lab-based or rapid) negative at time of enrollment

Able to provide informed consent

Have injected non-prescribed drugs within the past 6 months

Exclusion Criteria

Pregnant or breastfeeding people. Should a participant become pregnant, the treating physician will discuss with the participant whether to continue study medication, taking into consideration the risks and benefits of continuing cabotegravir compared with the risk of switching to an alternative recommended PrEP regimen

Has not had vaginal or anal sex in the past 6 months

I have an HIV positive or indeterminate test result before starting CAB PrEP.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

0-7 days

1 visit (in-person)

Enrollment and Initial Treatment

Participants complete a medical evaluation and receive the first CAB-LA injection

1 week

1 visit (in-person)

Treatment

Participants receive CAB-LA injections every 2 months for three additional doses

6 months

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 month

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Cabotegravir

Trial Overview The intervention being tested is APRETUDE (cabotegravir), a long-acting injectable medication designed to prevent HIV in people who might be exposed to the virus through injection drug use.

How Is the Trial Designed?

Group I: All participants Experimental Treatment 1 Intervention

All participants will receive long-acting injectable cabotegravir and a suite of support services, including PrEP navigation, transportation assistance, and financial incentives.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Fenway Community Health

Collaborator

Trials

36

Recruited

5,833,000+

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

Citations

1. viivhealthcare.com viivhealthcare.com/hiv-news-and-media/news/press-releases/2024/october/real-world-studies-for-apretude/

ViiV Healthcare shows more than 99% effectiveness in real ... ViiV HEALTHCARE SHOWS MORE THAN 99% EFFECTIVENESS IN REAL-WORLD STUDIES FOR APRETUDE (CABOTEGRAVIR LONG-ACTING), THE ONLY APPROVED LONG-ACTING ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10090368/

Safety and efficacy of long-acting injectable cabotegravir as ... CAB-LA is highly efficacious for HIV prevention with few safety concerns. CAB-LA may lead to an increased risk of INSTI resistance.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2352301823002618

Efficacy and safety of long-acting cabotegravir compared ... Injectable cabotegravir was superior to daily oral tenofovir disoproxil fumarate plus emtricitabine for HIV prevention in two clinical trials.

4. thelancet.com thelancet.com/journals/lanhiv/article/PIIS2352-3018(24)00310-2/fulltext

Safety, tolerability, and acceptability of long-acting ... Long-acting injectable cabotegravir is a safe, tolerable, and acceptable option for the prevention of HIV in adolescent girls. Our study ...

5. viivhealthcare.com viivhealthcare.com/hiv-news-and-media/news/press-releases/2025/october/nice-issues-positive-recommendation/

NICE issues positive recommendation for ViiV Healthcare's ... ViV Healthcare shows more than 99% effectiveness in real-world studies for Apretude (cabotegravir long-acting), the only approved long-acting ...

6. viivexchange.com viivexchange.com/en-gb/hiv-medicines/apretude/safety/

APRETUDE▼ (cabotegravir) Safety APRETUDE is generally well tolerated with low discontinuation rates. In HIV Prevention Trials Network (HPTN) 083, which included >2,000 cisgender men and ...

7. 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 Prospective CAB PK data during pregnancy and postpartum are limited to preliminary data from the HIV Prevention Trials Network (HPTN) 084 protocol open-label ...

8. apretudehcp.com apretudehcp.com/efficacy/hptn-083-efficacy/

HPTN 083 Clinical Trial Explore efficacy data, study design, and baseline characteristics for the HPTN 083 APRETUDE (cabotegravir 200 mg/mL) clinical trial. For US HCPs only.

9. nejm.org nejm.org/doi/full/10.1056/NEJMoa2101016

Cabotegravir for HIV Prevention in Cisgender Men and ... Injection-site reactions were reported in 81.4% of the participants in the cabotegravir group and in 31.3% of those in the TDF–FTC group. In the ...