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NIH STI Study Recruiting: 7 days on & 7 days off HAART
Department of Health and Human Services
  Name of Study:
A Randomized Controlled Trial of Short Cycle of Intermittent versus Continuous Highly Active Antiretroviral Therapy (HAART) for the Treatment of Chronic HIV Infection
Goal of Study:
Study the virologic and immunologic effects of short cycle intermittent versus continuous HAART in order to suppress viral replication, minimize toxicity and side effects, and reduce cost.
Eligibility Criteria:
1. 18 years of age or older with positive HIV-ELISA and Western Blot
2. Absolute CD4+ T cell count greater than or equal to 175/mm3 within 30 days before randomization.
3. History of at least 1 month of ongoing HAART, defined as at least 2 nucleoside reverse transcriptase inhibitors in combination with either a non-nucleoside reverse transcriptase inhibitor or a protease inhibitor.
4. History of viral levels less than 500 copies/mL for at least one month, and levels less than 50 copies/mL based on at least one determination within 30 days prior to enrollment.
5. Must not be receiving salvage HAART; must have no evidence of resistance to licensed anti-retroviral medications as determined by the principal investigator.
6. Must not have used experimental antiretrovirals less than 6 months prior to enrollment.
7. Asymptomatic for significant HIV-related illness, such as opportunistic infections and malignancies other than mucocutaneous Kaposi's Sarcoma; no significant cardiac, pulmonary, kidney, rheumatologic, gastrointestinal, hematologic, or CNS disease as detectable on routine history, physical examination, or screening laboratory studies.
8. Platelet count >50,000/mm3, creatinine <2.0, AST <5 times the normal laboratory values, total or direct bilirubin <2 times the normal laboratory values.
9. Must not have known history or laboratory evidence of chronic hepatitis B infection, including surface antigen positivity. 10. Negative pregnancy test.
Study Regimen:
Although highly active antiretroviral therapy (HAART) has been successful in suppressing plasma HIV levels in infected patients, virus replication persists and viral levels have been shown to rebound after withdrawing HAART. Long term use of HAART also carries risk of significant toxicity and side effects. This study proposes to study the virologic and immunologic effects of intermittent versus continuous HAART in HIV-infected individuals with goals of suppressing virus replication, minimizing the toxicity and side effects of HAART, and reducing cost. In this randomized controlled study, 45 individuals will be randomized to receive continuous HAART and 45 individuals will receive intermittent HAART with intervals of seven days off therapy followed seven days on therapy for 72 weeks. Blood will be drawn at the end of an off-drug period monthly or every other month. Participants will also undergo a leukapheresis before stopping medication and every 3 months thereafter. Patients must have viral load levels below 50 copies/mL and a CD4+ count of at least 175/mm3 one month prior to enrollment. We will analyze CD4+ T cell counts, viral load, incidence of toxicity and side effects and HIV-specific immune responses.
Person to contact: Diane M. Rock Kress, RN (301) 435-8003 or 1 (800) 772-5464 ext. 58003. Transportation/costs/stipend.
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