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

• Status: Completed
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

Summary

HIV infected children and adolescents who have taken many anti-HIV drugs may have limited treatment options and are at high risk for progressing to AIDS. The purpose of this study is to determine whether an anti-HIV treatment regimen of 2 protease inhibitors (PIs) and 2 nucleoside reverse transcriptase inhibitors (NRTIs) is more effective than a regimen of 4 NRTIs in treatment-experienced children and adolescents who have failed previous anti-HIV treatment.

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

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Abacavir; Emtricitabine; Lamivudine; Lopinavir; Ritonavir; Saquinavir; Tenofovir; Zidovudine

Criteria

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