Rilpivirine in Virologically Suppressed Adolescents

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

To describe the immunologic and virologic outcomes (HIV RNA, CD4) following switching from EFV to RPV in virologically suppressed adolescents

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mahidol University
• Collaborator: amfAR, The Foundation for AIDS Research
• Treatments: Rilpivirine

Criteria

Inclusion Criteria:

• HIV-infected adolescents aged 12-18 years;

• Body weight >25 kilograms;

• Currently treated with stable EFV-based HAART (EFV plus two nucleoside or nucleotide reverse transcriptase inhibitors [N(t)RTI]) for >3 months prior to enrollment;

• Plasma HIV RNA <50 copies/ml within the last 12 months;

• ALT <200 IU/L within the last 12 months;

• Caregivers give written informed consent and adolescents who know their HIV status (i.e., have been fully disclosed to) give assent

Exclusion Criteria:

• Has evidence of NNRTI-associated resistance mutation(s) from previous genotypic resistance testing;

• Currently has PI(s) in the HAART regimen;

• Has currently active HIV-related infection(s), (The subject can be enrolled after the infection is under controlled);

• Has significant medical problem(s) that would compromise study results (in the site principal investigator's opinion);

• Pregnancy (postpartum women are allowed);

• Concomitant treatment with drugs known to effect the PK of RPV (carbamazepine, phenobarbital, phenytoin, rifampicin, rifabutin, omeprazole, esomeprazole, lansoprazole, erythromycin, clarithromycin, azithromycin, roxithromycin)