A Study of the Safety and Effectiveness of Treating Advanced AIDS Patients Between Ages 4 and 22 With 7 Drugs, Some at Higher Than Usual Doses

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

Clinicians are increasingly confronted with HIV-positive children who have failed all available antiretroviral therapies and have few viable treatment options. Virologic failure in these patients may be a result of antiretroviral resistance, likely a result of poor adherence to the treatment regimen or inadequate dosing. This study is designed to achieve adherence through observation of drug administration for the first 8 weeks of the study and to further overcome resistance by intensive, high-dose, multi-drug therapy. Treatment with more than 4 drugs has not been studied formally in childr...

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Patients may be eligible for this trial if they:
• • Are HIV-positive.
• • Have HIV levels of 10,000 copies/ml or more.
• • Are between ages 4 and 22.
• • Have motivation and ability to conform to the complex treatment regimen.
• • Agree to practice abstinence or use 2 effective methods of birth control during the study and until 3 months after stopping the study drugs, if sexually active.
• • Have written informed consent from a parent or legal guardian if under age 18.
• • Have used at least 3 different nucleoside reverse transcriptase inhibitors (NRTIs) for at least 3 months each or have shown resistance to at least 3 different NRTIs.
• • Have used at least 1 nonnucleoside reverse transcriptase inhibitor (NNRTI) for at least 3 months each or have shown resistance.
• • Have used at least 2 different courses of a protease inhibitor (PI)-containing regimen, each of which was at least 6 months, or have evidence of mutations to at least 2 different PIs.
• • This study has been changed. The inclusion criteria reflects a change in the prior anti-HIV therapy required, age requirement, and the required CD4 and HIV levels.
• • Exclusion Criteria
• Patients will not be eligible for this trial if they:
• • Are allergic to even 1 study drug or have ever had to stop 1 of these drugs because of a bad reaction to it.
• • Have a history of diabetes, hepatitis C, hepatitis B, or certain diseases of the nervous system, heart, or pancreas.
• • Have had a serious infection within 14 days of starting the study.
• • Need certain drugs that interact with the study drugs. (See Technical Summary for more details.)
• • Are pregnant or breast-feeding.
• • Have had hepatitis within 30 days of study entry.