Cabotegravir And Rilpivirine: Efficacy and Safety Study (CARES)
- Conditions
- HIV/AIDS
- Registration Number
- PACTR202104874490818
- Lead Sponsor
- Joint Clinical Research Centre Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other
- Sex
- All
- Target Recruitment
- 512
1. Male or female
2. Aged =18 years.
3. On a stable ARV regimen(TDF plus either 3TC or FTC, plus an INI [DTG]or a NNRTI [EFV or NVP]per local country guidelines)for at least 6 months prior to screening.
4. Virologically suppressed with documented evidence of:
? Viral load <50 c/mL at screening AND ? Viral load <50 c/mL on a test preceding screening (within 4-12 months prior to screening) AND ? No two consecutive viral load tests =50 c/mL in the 12 months prior to screening
5. No prior history o f virologic failure (defined as a confirmed plasma HIV-1 RNA measurement >200c/mL) at any time.
6. Must sign an ICF indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.
7. A female participant is eligible to participate if she is not pregnant (as confirmed by a negative human chorionic gonadotrophin [hCG] urine test at screening and a negative urine hCG test at randomization) and not lactating.
8. A male participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another. Male participants should also be advised of the benefit for a female partner to use a highly effective method of contraception as condom may break or leak.
9. Male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 90 days after receiving the last dose of study intervention.
10. Participants with asymptomatic chronic hepatitis C virus (HCV) infection will be allowed entry if liver enzymes meet entry criteria, have undergone appropriate work-up, and are not in an advanced, unstable liver disease stage.
11. Is willing and able to adhere to the lifestyle restrictions specified in this protocol.
1. Is currently participating in any other interventional study.
2. Is pregnant, breastfeeding or intends to become pregnant or breastfeed during the study, within the next 1 year.
3. Has evidence of an active Center for Disease Control and Prevention (CDC) Stage 3 disease, except cutaneous Kaposi’s sarcoma not requiring systemic therapy and historical or current CD4 cell counts less than 200 cells/mm3
4. Has active TB co-infection and requires anti-TB treatment.
5. Has severe hepatic impairment, history of liver cirrhosis with or without hepatitis viral co-infection.
6. Has preexisting physical or mental condition (including substance abuse disorder and suicide risk) which, in the opinion of the Investigator, may interfere with the participant’s ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the participant.
7. Has had more than one seizure within one year (defined as within 365 days) prior to entry, or unstable or poorly controlled seizure disorder, as determined by the investigator or designee, based on available medical records.
8. Has a tattoo or other dermatological condition overlying the gluteus region.
9. Is positive for HBsAg or anti-HBc at screening.
10. Has ongoing or clinically significant medical conditions that in the opinion of the investigator may interfere with the absorption, distribution, metabolism or excretion of the study interventions or could affect participant safety.
11. Has a history o f coagulopathies, or current or anticipated need for chronic anticoagulationexcept forlow dose acetylsalicylic acid (daily dose =325mg).
12. Has known major INI or NNRTI resistance-associated mutation as defined in the International Antiviral Society-USA 2019 list, except for K103N, based on any historical resistance test result.
13. Has any verified Grade 4 laboratory abnormality.
*More exclusion criteria in the study protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Plasma HIV-1 RNA <50 c/m
- Secondary Outcome Measures
Name Time Method Confirmed virologic failure (2 consecutive plasma HIV-1 RNA levels =200c/mL);Virological non-response (plasma HIV-1 RNA =50 c/mL);Plasma HIV-1 RNA <50 c/mL;Change from baseline in CD4+ lymphocyte count ;Incident disease progression (HIV-associated conditions, AIDS and death);Incident Grade 3 and Grade 4 AEs;Adverse events leading to treatment discontinuation