What side effects are associated with this type of intervention?

Common side effects of integrase strand transfer inhibitors (INSTIs) like Cabotegravir include headache, nausea, and diarrhea. Some patients may also experience insomnia and fatigue. Non-nucleoside reverse transcriptase inhibitors (NNRTIs) such as Rilpivirine can cause side effects like depression, insomnia, headache, and rash. Both classes of drugs are generally well-tolerated, but patients should be monitored for these potential adverse effects.

What prior FDA approvals exist?

The FDA has approved several integrase strand transfer inhibitors (INSTIs) and non-nucleoside reverse transcriptase inhibitors (NNRTIs) for the treatment of HIV. Key INSTIs include dolutegravir, raltegravir, and elvitegravir, which are known for their efficacy in inhibiting the integration of viral DNA into the host genome. Rilpivirine, an NNRTI, has also been approved and is used to inhibit the reverse transcription of viral RNA into DNA. These drugs, often used in combination with other antiretrovirals, form the backbone of modern HIV therapy, similar to the combination being studied in the CAB-RPV LA trial.

What other types of research exist?

Promising novel alternatives to CAB-RPV LA for HIV treatment in 2024 include long-acting injectable formulations such as Lenacapavir, an HIV capsid inhibitor, and Islatravir, a nucleoside reverse transcriptase translocation inhibitor. Both drugs are in advanced stages of clinical development and offer the potential for less frequent dosing schedules, which can improve adherence and patient outcomes.

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Novel Delivery System for HIV Treatment

N/A

Waitlist Available

Led By Albert Liu, MD, MPH

Research Sponsored by Public Health Foundation Enterprises, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0, 9,18 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests an injection for trans women living with HIV. The injection combines two medications to control the virus and is easier to stick to than daily pills. The study aims to help trans women who have trouble with typical treatments.

Who is the study for?

This trial is for transwomen living with HIV who are over 18, speak English, and have controlled HIV levels. They must be interested in a new injection treatment (CAB-RPV LA), receive care at certain clinics, and have a cell phone. People can't join if they can't get gluteal injections, plan to move soon, have drug-resistant HIV strains or take certain medications.

What is being tested?

The study tests an integrated delivery model of CAB-RPV LA injections for transwomen with HIV. It includes patient-centered injection sites and adherence support, provider education, and improved clinic communication strategies.

What are the potential side effects?

While the trial doesn't list specific side effects for CAB-RPV LA injections, common ones may include pain at the injection site, headache, feverish symptoms or fatigue. Each person's experience with side effects could vary.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0, 9,18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0, 9,18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0, 9,18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability of delivering CAB-RPV LA

Client Satisfaction

Feasibility of delivering CAB-RPV LA

Secondary study objectives

Assess adherence to injections

Assess tolerability

Assess viral suppression

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Cheeky Study InterventionExperimental Treatment4 Interventions

This study represents a hybrid design type 3 focusing primarily on implementation outcomes and secondarily on clinical effectiveness among trans women living with HIV receiving care within primary care clinics in San Francisco. A type 3 design was chosen, as the clinical efficacy of CAB- RPV LA has been established in clinical trials, and the focus of this study is on initial implementation of CAB-RPV LA within these clinics.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Integrase strand transfer inhibitors (INSTIs), such as Cabotegravir, work by blocking the HIV integrase enzyme, which is essential for the viral DNA to integrate into the host cell's genome. This prevents the virus from replicating and spreading to new cells. Non-nucleoside reverse transcriptase inhibitors (NNRTIs), like Rilpivirine, inhibit the reverse transcriptase enzyme, which is crucial for converting viral RNA into DNA. By binding to a specific site on the enzyme, NNRTIs prevent the transcription process, thereby reducing viral replication. These mechanisms are vital for HIV patients as they help to control the viral load, improve immune function, and reduce the risk of developing AIDS-related complications.