A Study to Compare Two Different Anti-HIV Drug Regimens

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

Keywords

ClinConnect Summary

The use of combination therapy with 2 or more antiretroviral agents has been strongly supported by recent studies in both children and adults. However, as of yet, few combinations of antiretrovirals have been studied in large cohorts of stable HIV-1 infected, antiretroviral-experienced children. Evidence suggests that viral suppression may be more difficult to achieve in children. Therefore, it is important to develop new drug combinations which can maximally suppress plasma HIV-1 RNA concentrations in children.

Patients are stratified by prior antiretroviral treatment (zidovudine \[ZDV\]/...

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Patients may be eligible for this study if they:
• • Are between 4 months and 21 years of age (consent of parent or guardian required if under 18).
• • Are HIV-positive.
• • Have a viral level of at least 4,000 copies/ml.
• • Have a CD4 cell count of at least 750 (under 12 months of age), at least 500 (1 to 5 years of age), or at least 200 (6 years of age or older) cells/mm3 within the past 4 months or a CD4 percent of 15 percent or higher within the past 4 months.
• • Have received the same continuous antiretroviral therapy for the past 16 weeks.
• • Exclusion Criteria
• Patients will not be eligible for this study if they:
• • Have an active opportunistic and/or serious bacterial infection.
• • Have been diagnosed with a malignancy.
• • Have received prior treatment with certain antiretroviral medications.
• • Are pregnant or breast-feeding.