HIV Infections Clinical Trial
Official title:
Partial Treatment Interruptions in HIV-1 Patients With Multi-Drug Resistant Virus
The goal of this study is to examine whether enfuvirtide (T20, Fuzeon) has continued anti-HIV activity in patients experiencing an incomplete virologic response to an enfuvirtide-based regimen.
Some patients do not achieve an undetectable HIV viral load with an enfuvirtide (T20,
Fuzeon) based antiretroviral regimen. As a consequence, enfuvirtide resistant virus can
emerge. It is not yet known if enfuvirtide has continued virologic or immunologic benefit
after the drug-resistant variant emerges. Interrupting enfuvirtide may reduce the
accumulation of enfuvirtide mutations and may allow for a potent response of enfuvirtide
with future regimens.
Subjects must have evidence of viral replication (HIV RNA > 1,000 copies/ml on two
consecutive measurements) while on a stable antiretroviral regimen containing enfuvirtide.
Patients will then interrupt enfuvirtide while continuing all other antiretroviral agents.
Subjects will be seen weekly for four weeks, every two weeks for an additional 8 weeks, and
then every four weeks through week 48.
Plasma HIV RNA levels and CD4+/CD8+ T cell counts will be measured in real time at each
visit, and provided to the referring primary care physician. Subjects will be allowed to
resume enfuvirtide at any time during the course of this study. Subjects will be encouraged
to resume enfuvirtide (with or without modifying the background regimen) if plasma HIV RNA
levels increase by > 0.5 log on two consecutive occasions. Subjects are seen every four
weeks for 24 weeks after enfuvirtide is resumed.
Plasma will be collected at those visits for HIV RNA and stored for retrospective
genotype/phenotype evaluation.
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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