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Sponsored by: |
Agouron Pharmaceuticals |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00005001 |
The purpose of this study is to see if giving HIV-positive patients an HIV vaccine plus anti-HIV drugs can help lower HIV levels in the blood (viral load).
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Biological: HIV-1 Immunogen |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Double-Blind, Efficacy Study |
Official Title: | A Pilot, Phase II, Double-Blind Study to Assess the Virologic Effect of Remune Versus Incomplete Freund's Adjuvant (IFA) in Patients Who Are Infected With Human Immunodeficiency Virus Type I (HIV-1), Have a Plasma HIV-1 RNA Level Less Than 50 Copies/Ml, Are Receiving Highly Active Antiretroviral Therapy (HAART), and Who Subsequently Discontinue Their HAART Regimen |
Estimated Enrollment: | 40 |
At the time of study entry, all patients are receiving a HAART regimen consisting of three drugs from at least two classes of antiretroviral drugs. Upon entering the study, patients receive Remune or IFA at Weeks 0, 12, and 24. Patients remain on study for 40 weeks. Patients who have received three injections of Remune or IFA and whose plasma HIV-1 RNA level is less than 50 copies/ml at Week 26 discontinue HAART at Week 28. (If the patient has a plasma HIV-1 RNA level at or above 50 copies/ml at Week 26, he/she must have a measurement below 50 copies/ml at Week 27 to proceed with HAART discontinuation at Week 28. If by Week 27 the patient does not have a plasma HIV-1 RNA level below 50 copies/ml, the patient does not discontinue HAART but remains on study and has study visits at Weeks 34 and 40.) Patients who discontinue HAART have their plasma HIV-1 RNA levels measured on the day HAART is discontinued and at Days 3, 5, 7, 10, 14, 21, 28, 35, and 42 after discontinuation. Patients with a plasma HIV-1 RNA level of at least 5,000 copies/ml at Week 34 restart HAART at that time. (Patients whose plasma HIV-1 RNA level reaches greater than or equal to 100,000 copies/ml on two occasions before Week 34 have the option of restarting HAART immediately.) Patients whose plasma HIV-1 RNA level is less than 5,000 copies/ml at Week 34 do not restart HAART unless their level increases to at least 5,000 copies/ml. Patients who discontinue HAART are monitored intensively for the duration of the study. Patients have 27 visits if they stay on study until completion at Week 40.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients may be eligible for this study if they:
Study ID Numbers: | B008, AG1661-201 |
Study First Received: | March 21, 2000 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00005001 |
Health Authority: | United States: Food and Drug Administration |
HIV-1 Drug Therapy, Combination RNA, Viral |
Anti-HIV Agents Viral Load remune |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Seropositivity HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Freund's Adjuvant Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |