A Phase II, Randomized, Open-Label Study to Evaluate the Safety and Effectiveness of Two Antiretroviral Therapeutic Strategies: A Dual PI-Based HAART Regimen Versus a Multi-NRTI ART Regimen, in ART-Experienced Children and Youth Who Have Experienced Virologic Failure

NCT00102206 Phase 2 COMPLETED

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.

Details

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 2
Status	COMPLETED
Enrolment	6
Completion	2007-05

Conditions

• HIV Infections

Interventions

• Abacavir sulfate
• Emtricitabine
• Lamivudine
• Lopinavir/ritonavir
• Saquinavir
• Tenofovir disoproxil fumarate
• Zidovudine

Primary outcomes

• Tolerability of dual PI-based HAART versus multi-NRTI HAART salvage regimens (time to first intolerant event)
• 95% confidence interval (CI) for change in CD4% computed for PI-containing groups versus PI-sparing group
• 95% CI for change in BMD (both percent change in BMD and change in z-score from baseline) for each treatment group

Countries

United States