Study of a New Anti-HIV Drug, T-20, in HIV-Infected Children

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

Keywords

ClinConnect Summary

T-20 is the first drug to be developed which specifically inhibits the function of the gp41 transmembrane glycoprotein. By inhibiting the essential protein-protein surface interaction, T-20 is able to block the process of virus-to-host cell membrane fusion. Combination antiretroviral regimens (reverse transcriptase inhibitors plus PIs) have benefited many HIV patients, but heavily pretreated patients often develop multi-drug resistance via multiple gene mutations. A pharmacologic agent, such as T-20, that is effective at an alternative point in the virus replication cycle will make a valuab...

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Eligibility criteria

• • Inclusion Criteria
• Children may be eligible for this study if they:
• • Are 3 to 12 years old (consent of parent or guardian required).
• • Are HIV-positive.
• • Are receiving combination anti-HIV therapy. He/she must have been taking this combination for at least 16 weeks, and it must include either 2 NRTIs alone or 2 NRTIs plus either an NNRTI or a PI. (This study has been changed. This no longer has to be a child's first anti-HIV drug combination.)
• • Have a viral load greater than 10,000 copies/ml while taking this anti-HIV drug combination.
• • Have never received treatment with a PI or an NNRTI. (One or two doses are allowed.)
• • Have never taken at least 1 NRTI.
• • Exclusion Criteria
• Children will not be eligible for this study if they:
• • Are receiving treatment for an opportunistic (AIDS-related) or serious bacterial infection at the time of study entry.
• • Are receiving chemotherapy for cancer.
• • Have certain serious diseases (other than HIV) or conditions.
• • Have received or are currently receiving certain medications.
• • Are pregnant.