Study to Evaluate the Efficacy, Safety, and Tolerability of Long-acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch From an Integrase Inhibitor in HIV-1 Infected Therapy Naive Participants
- Conditions
- HIV-Infection
- Registration Number
- JPRN-jRCT2080223432
- Lead Sponsor
- GlaxoSmithKline K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 631
1. HIV-1 infected, ART-naive men or women aged 18 years or greater at the time of signing the informed consent.
2. HIV-1 infection as documented by Screening plasma HIV-1 RNA >- 1000 c/mL
3. Antiretroviral-naive (<-10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection). Any previous exposure to an HIV integrase inhibitor or non-nucleoside reverse transcriptase inhibitor will be exclusionary.
4. A female participant is eligible to participate if she is not pregnant or not lactating, and at least one of the following conditions applies:
a. Non-reproductive potential
b. Reproductive potential and agrees to follow one of Highly Effective Methods for Avoiding Pregnancy from 30 days prior to the first dose of study medication, throughout the study, and for at least 30 days after discontinuation of all oral study medications and for at least 52 weeks after discontinuation of all injectable study medications.
1. Women who are pregnant, breastfeeding, or plan to become pregnant or breastfeed during the study.
2. Any evidence at Screening of an active Centers for Disease and Prevention Control (CDC) Stage 3 disease , except cutaneous Kaposi's sarcoma not requiring systemic therapy or historic or current CD4+ cell count <200 cells/mm3 are not exclusionary.
3. Participants with known moderate to severe hepatic impairment.
4. Evidence of Hepatitis B virus (HBV) infection based on the results of testing at Screening for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (anti-HBc), Hepatitis B surface antibody (anti-HBs) and HBV DNA as follows
-Participants positive for HBsAg are excluded;
-Participants negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and positive for HBV DNA are excluded.
Note: Participants positive for anti-HBc (negative HBsAg status) and positive for anti-HBs (past and/or current evidence) are immune to HBV and are not excluded
5. History of liver cirrhosis with or without hepatitis viral co-infection.
6. Ongoing or clinically relevant pancreatitis.
7. All participants will be screened for syphilis (rapid plasma reagin [RPR]). Participants with untreated syphilis infection, defined as a positive RPR without clear documentation of treatment, are excluded. Participants with a positive RPR test who have not been treated may be rescreened at least 30 days after completion of antibiotic treatment for syphilis.
8. Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical, anal or penile intraepithelial neoplasia; other localized malignancies require agreement between the investigator and the study Medical Monitor for inclusion of the participant prior to enrolment.
9. Any evidence of primary resistance to NNRTIs (except for K103N which is allowed), or any known resistance to INIs from historical resistance test results (International AIDS Society [ IAS]-USA, 2015). Note: Re-tests of Screening genotypes are allowed only at the discretion of the study virologist.
10. Participants who are HLA-B*5701 positive and are unable to use an NRTI backbone that does not contain abacavir (participants who are HLA-B*5701 positive may be enrolled if they use a NRTI backbone that does not contain abacavir; HLA-B*5701 positive participants may be excluded from the study if local provision of an alternate NRTI backbone is not1. Women who are pregnant, breastfeeding, or plan to become pregnant or breastfeed during the study.
2. Any evidence at Screening of an active Centers for Disease and Prevention Control (CDC) Stage 3 disease , except cutaneous Kaposi's sarcoma not requiring systemic therapy or historic or current CD4+ cell count <200 cells/mm3 are not exclusionary.
3. Participants with known moderate to severe hepatic impairment.
4. Evidence of Hepatitis B virus (HBV) infection based on the results of testing at Screening for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (anti-HBc), Hepatitis B surface antibody (anti-HBs) and HBV DNA as follows
-Participants positive for HBsAg are excluded;
-Participants negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and positive for HBV DNA are excluded.
Note: Participants positive for anti-HBc (negative HBsAg status) and positive for anti-HBs (past and/or current evidence) are immune to HBV and are not excluded
5. History o
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method