Clinical trial for HIV Infections
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?
CAB ULA is an investigational medicine, being studied as a potential treatment for hiv infections.
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
- This study compares the efficacy, safety and tolerability of CAB ULA and RPV ULA administered with CAB long acting (LA) and RPV LA administered in adults and adolescents with HIV who are virologically suppressed on anti-retroviral therapy (ART).
- 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.
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 HIV.
- Previous exposure to CAB and/or 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...
See the full eligibility criteria
- 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 been done for virologic treatment failure (HIV-1 RNA ≥200 copies/mL).
- 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 mutation.
- Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of screening.
- Any history of receiving long-acting therapy for HIV.
- Previous exposure to CAB and/or 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 safety or study participation. Note: Other protocol defined...
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Bakersfield, California, United States
- Los Angeles, California, United States
- San Diego, 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
- 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
- Grosse Pointe Woods, Michigan, United States
- Kansas City, Missouri, United States
- Las Vegas, Nevada, United States
- Newark, New Jersey, United States
- Santa Fe, New Mexico, United States
+ 46 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 - 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?
Study sites include Phoenix, Arizona, United States; Bakersfield, California, United States; Los Angeles, California, United States; San Diego, California, United States; New Haven, Connecticut, United States; Washington D.C., District of Columbia, United States and 60 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.