Effectiveness of Treating HIV-Positive Patients With an HIV Vaccine (Remune)
Recruitment status was Active, not recruiting
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The purpose of this study is to see if it is effective to add an HIV vaccine (Remune) to the anti-HIV drug combination of Combivir (zidovudine plus lamivudine) and nelfinavir.
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Drug: Lamivudine/Zidovudine Biological: HIV-1 Immunogen Drug: Nelfinavir mesylate |
Phase 3 |
Study Type: | Interventional |
Study Design: | Endpoint Classification: Efficacy Study Masking: Double-Blind Primary Purpose: Treatment |
Official Title: | A Randomized, Double-Blind, Adjuvant-Controlled, Multicenter Study to Compare the Virologic and Immunologic Effect of Highly Active Antiretroviral Therapy (HAART) Plus Remune Versus HAART Plus Incomplete Freund's Adjuvant (IFA) in Antiretroviral-Naive Patients Infected With Human Immunodeficiency Virus Type 1 (HIV-1) |
Estimated Enrollment: | 688 |
All patients begin HAART at study entry (Day 1). Patients with a plasma HIV-1 RNA level less than or equal to 2,000 copies/ml at Week 8 are randomized to receive Remune or Incomplete Freund's Adjuvant (IFA) at Week 9. Patients who do not achieve a plasma HIV-1 RNA level of less than or equal to 2,000 copies/ml at Week 8 are not randomized and are terminated from the study. These patients are eligible to receive funding for up to a 3-month supply of nelfinavir (Viracept) and Combivir. Randomized patients receive Remune or IFA at Week 9 and approximately every 12 weeks thereafter until study completion (when the last patient reaches Week 48). Patients are considered virologic failures if they (1) fail to achieve a virologic response by Week 48 or (2) after achieving a virologic response, have a virologic relapse. Regardless of their previous response status, patients whose plasma HIV-1 RNA level increases to greater than 2,000 copies/ml while they are receiving protocol-specified HAART are eligible to receive salvage therapy and continue to receive Remune or IFA until study completion. Study visits occur at screening, Day 1, Weeks 4, 8, 9, 12, and then every 4 weeks thereafter until the last patient reaches Week 48. Patients who complete this study are eligible to participate in a rollover study.
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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:
- Are HIV-positive.
- Are at least 13 years old (consent of parent or guardian required if under 18).
- Have a viral load of at least 10,000 copies/ml.
- Have a CD4 count of at least 250 cells/mm3.
- Have never taken any anti-HIV drugs before.
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No publications provided
ClinicalTrials.gov Identifier: | NCT00005002 History of Changes |
Other Study ID Numbers: | B009, AG1661-202 |
Study First Received: | March 21, 2000 |
Last Updated: | June 23, 2005 |
Health Authority: | United States: Food and Drug Administration |
Keywords provided by NIH AIDS Clinical Trials Information Service:
HIV-1 Drug Therapy, Combination HIV Protease Inhibitors CD4 Lymphocyte Count Nelfinavir |
Reverse Transcriptase Inhibitors Anti-HIV Agents Viral Load remune Combivir |
Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases Zidovudine Lamivudine Reverse Transcriptase Inhibitors |
Lamivudine, zidovudine drug combination Nelfinavir HIV Protease Inhibitors Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents Protease Inhibitors |
ClinicalTrials.gov processed this record on March 14, 2013