A Comparison of Two Anti-HIV Drug Regimens for Youth Who Have Failed Prior Therapy

Inclusion Criteria for Step I: HIV infected No currently available therapeutic options that would likely result in long-term suppression of virus to less than 400 copies/ml Two measurements within 4 months prior to screening and at screening of either CD4% of less than 15% and HIV viral load of greater than 10,000 copies/ml OR HIV viral load greater than 30,000 copies/ml Previous exposure to non-nucleoside reverse transcriptase inhibitors (NNRTIs), NRTIs, and PIs AND have experienced virologic failure. More information on previous treatment regimen requirements is available in the protocol. Prior or current virologic failure with genotypic or phenotypic resistance OR historical virologic failure with a PI- or NNRTI-containing regimen Resistance to 2 or more drugs in most recent treatment regimen within 26 weeks prior to study screening Able and willing to swallow study medications Parent or guardian willing to provide informed consent, if applicable Willing to use acceptable methods of contraception Exclusion Criteria for Step I: Previous cumulative exposure to TDF for more than 24 weeks OR more than 14 days of TDF exposure during the 24 weeks prior to study entry Grade 1 lipase or higher within 28 days prior to study entry Grade 3 or higher laboratory abnormality (except for lipase) within 28 days prior to study entry History of allergy or hypersensitivity to any of the study drugs Active CDC Stage C opportunistic infection or serious bacterial infection requiring therapy at the time of screening Chemotherapy for active cancer Require certain medications Abnormal kidney function Any clinically significant diseases other than HIV infection or findings during medical history screening that, in the opinion of the investigator, may interfere with the study Pregnancy or breastfeeding