Clinical trial for HIV
Official title A Study to Investigate Cabotegravir Ultra Long-Acting (CAB ULA) Plus Rilpivirine Ultra Long-Acting (RPV ULA) in Adults and Adolescents With HIV Who Are Virologically Suppressed
ClinicalTrials.gov ID: NCT07650916
What this study is testing
What is CAB ULA?
an investigational long‑acting injectable medicine being studied as a potential treatment for HIV infection is designed to block the HIV integrase enzyme, preventing the virus from inserting its genetic material into host cells
Also referred to as cabotegravir.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to learn how effective, safe, and tolerable these injectable medicines are compared with current oral therapy.
- Who it's for
- Adults and adolescents with HIV who have a suppressed viral load while on antiretroviral therapy.
- What's involved
- Participants will receive injections of cabotegravir and rilpivirine and attend clinic visits for dosing and safety monitoring.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- Patient Study Participant (PSP) Adults and adolescents with HIV-1 infection aged 12 years or older with a weight \>35 kg.
- Documented HIV-1 RNA measurements \<50 copies/mL in the 12 months prior to Screening.
- HIV-1 RNA \<50 copies/mL at screening assessment.
- Must be on current daily oral antiretroviral regimen for at least 6 months uninterrupted prior to Screening.
- Any prior switch in therapy must have occurred due to side effects/safety, access to medications, or convenience/simplification, and must NOT have...
You likely can't join if
- Patient Study Participant (PSP) Exclusion criteria
- Any evidence of primary resistance based on the presence of any major known INSTI (including CAB) or NNRTI (including RPV) resistance-associated...
- Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of screening
- Any history of receiving long-acting therapy for treatment or prevention of HIV
- Previous exposure to injectable CAB and/or injectable RPV for treatment or prevention of HIV-1 infection
- Significant uncontrolled or clinically relevant comorbidities (e.g., cardiovascular, hepatic, renal, neurological, psychiatric) that may impact...
The study team makes the final eligibility decision.
Where it is enrolling
- Phoenix, Arizona, United States
- Bakersfield, California, United States
- Los Angeles, California, United States
- San Diego, California, United States
- West Hollywood, California, United States
- New Haven, Connecticut, United States
- Washington D.C., District of Columbia, United States
- DeLand, Florida, United States
- Fort Lauderdale, Florida, United States
- Ft. Pierce, Florida, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Pensacola, Florida, United States
- Vero Beach, Florida, United States
- West Palm Beach, Florida, United States
- Decatur, Georgia, United States
- Chicago, Illinois, United States
- Baltimore, Maryland, United States
- Grosse Pointe Woods, Michigan, United States
+ 64 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Phoenix, Arizona, United States; Bakersfield, California, United States; Los Angeles, California, United States; San Diego, California, United States; West Hollywood, California, United States; New Haven, Connecticut, United States and 78 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.