NNRTI vs PI Regimens for HIV Infected Women After They Have Taken Nevirapine to Prevent Mother-To-Child HIV Transmission (OCTANE)
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Treatment Experienced, Treatment Naive, MTCT, HIV Seronegativity
Eligibility Criteria
Inclusion Criteria for All Participants: HIV infected CD4 count less than 200 cells/mm^3 within 90 days prior to study entry Plasma HIV-1 RNA using standard Roche Amplicor HIV-1 Monitor Assay within 45 days prior to study entry the following laboratory values obtained within 45 days prior to study entry: absolute neutrophil count>=750/mm^3;Hemoglobin>=7.0g/dL;platelet count>=50000/mm^3;aspartate aminotransferase (AST),Alanine aminotransferase (ALT), and alkaline phosphatase <=2.5 x ULN; total bilirubin <=2.5 x ULN Normal renal function within 45 days prior to study entry Willing to use acceptable forms of contraception Karnofsky performance score >=70 on at least one occasion within 45 days prior to study entry Parent or guardian willing to provide informed consent, if applicable Planning to remain in the same geographical area of residence and are willing to attend study visits as required Inclusion Criteria for Trial 1 Participants: Previously received NVP for prevention of MTCT of HIV Has documentation of all prior doses of NVP used for prevention of MTCT of HIV Last dose of NVP for prevention of MTCT of HIV taken at least 6 months prior to study entry Exclusion Criteria for All Participants: Previously received any antiretrovirals, excluding NVP for MTCT prophylaxis for Trial 1 participants. Participants who have received up to 10 weeks of zidovudine alone and completed this course at least 6 months prior to study entry are not excluded. Use of systemic cancer chemotherapy, systemic investigational agents, immunomodulators, or rifampin within 30 days of study entry Pregnant or breastfeeding Known allergy or sensitivity to study drugs or their formulations Any condition, including drug or alcohol abuse, that, in the opinion of the investigator, may interfere with adherence to study regimens Serious illness requiring systemic treatment or hospitalization. Participants who complete therapy or are clinically stable on therapy for at least 30 days prior to study entry are not excluded. Tuberculosis (TB) treatment within 30 days prior to study entry Use of any prohibited medications within 30 days prior to study entry Involuntary incarceration in a correctional facility, prison, or jail for legal reasons or in a medical facility for treatment of either a psychiatric or physical illness
Sites / Locations
- The Gaborone BHP Study Clinic
- Molepolole BHP Study Clinic, Scottish Livingstone Hospital
- Moi University International Clnical Trials Unit
- KMRI / Walter Reed Project Clinical Research Center
- University of North Carolina Project (UNC Project)
- University of KwaZulu Natal
- Chris Hani Baragwanath Hospital, Johannesburg
- University of Witwatersrand
- Joint Clinical Research Centre (JCRC)
- Centre for Infectious Disease Research in Zambia (CIDRZ)
- University of Zimbabwe
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
NVP/NVP
NVP/LPV_r
NoNVP/NVP
NoNVP/LPV_r
For participants who had SD NVP exposure prior to study entry. FTC, TDF, and NVP daily the first 14 days, then twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV twice daily plus two more NRTIs.
For participants who had SD NVP exposure prior to study entry. FTC and TDF daily and LPV/RTV twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily for 14 days before taking it twice daily. plus 2 more NRTIs.
For participants who did NOT have SD NVP exposure prior to study entry.FTC, TDF, and NVP daily the first 14 days, then twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV twice daily plus two more NRTIs.
For participants who did NOT have SD NVP exposure prior to study entry. FTC and TDF daily and LPV/RTV twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily for 14 days before taking it twice daily. plus 2 more NRTIs.