Intermittent Versus Continuous Medication in the Treatment of HIV
Status:
Completed
Trial end date:
2004-11-01
Target enrollment:
Participant gender:
Summary
Although highly active antiretroviral therapy (HAART) has been successful in suppressing
plasma HIV RNA levels in infected patients, it has not resulted in eradication of virus. It
is now clear that virus replication persists despite undetectable plasma viremia in
individuals receiving HAART. In this regard, withdrawing HAART, even after prolonged periods
of virus suppression, leads to an almost universal rapid rebound of plasma viremia. It is
also now clear that prolonged, continuous HAART carries a risk of significant toxicity and
side effects. These recent observations may argue for a different approach to HAART with the
goals of: 1) durable suppression of virus replication, without an attempt at eradication, and
2) minimization of toxicity and side effects and improvement in patient life-style.
Therefore, we propose to study the virologic and immunologic effects of intermittent versus
continuous HAART in HIV-infected individuals as a possible means to achieve these goals. The
primary protocol, Cohort 1, will be a randomized controlled study of 35 individuals receiving
continuous HAART and 35 individuals receiving intermittent HAART with intervals of one month
off therapy followed by two months on therapy. A second cohort of 10 individuals will serve
as a pilot of 2 arms of 5 patients each to evaluate the potential of shorter on-off cycles to
maintain suppression of plasma virus and boost HIV-specific immune responses. An extension of
Cohort 2 will add 5 patients to the 7 days on/7 days off HAART arm with modified exclusion
criteria and procedure schedule. We will analyze CD4+ T-cell counts, viral load, incidence of
toxicity and side effects, HIV-specific immune responses and viral resistance to therapy and
characterize the virus during rebound plasma viremia.
Phase:
Phase 4
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)