Long-Term Effects of HAART in Youth With Stronger Immune Systems Versus Youth With Weaker Immune Systems

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

Keywords

ClinConnect Summary

Recent adult clinical trials involving combination HAART, including a protease inhibitor (PI), have demonstrated improvements in somatic immune system functioning. \[AS PER AMENDMENT 2/27/01: More recently, similar success has been demonstrated with a PI-sparing regimen, zidovudine, lamivudine, and efavirenz.\] Not all individuals, however, experience the same level of immune reconstitution, and oftentimes any improvement is short-lived. Adolescent patients may have a greater potential for immune restoration because of residual thymic tissue and therefore may experience greater long-term vi...

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Eligibility criteria

• • Inclusion Criteria
• Children may be eligible for this study if they:
• • Are HIV-positive.
• • Are between 8 and 22 years old (consent of parent or guardian required if under 18).
• • Have detectable levels of HIV in the blood within 30 days prior to study entry.
• • Expect to be on the study for at least 1 year. (This study has been changed by adding this requirement.)
• • Are pregnant and are not taking didanosine/stavudine (ddI/d4T) or EFV as part of their HAART regimen. (This study has been changed so that pregnant patients may be eligible if they are not taking ddI/d4T or EFV.)
• • Exclusion Criteria
• Children will not be eligible for this study if they:
• • Are taking HAART or more than 1 anti-HIV drug.
• • Were infected with HIV before birth, at the time of delivery, or by a blood transfusion during birth.
• • Have taken part in the study before.
• • Have not responded well to HAART in the past.
• • Have taken drugs to boost the immune system such as HIV vaccines, IVIG, or cytokine therapy.
• • Have AIDS-related (opportunistic) infection at the time of screening. (This study has been changed so that patients with an AIDS-related infection are ineligible.)
• • Are pregnant and are taking ddI/d4T or EFV as part of their HAART regimen. (This study has been changed so that pregnant patients are ineligible if they are taking ddI/d4T or EFV.)