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Effectiveness of Treating HIV-Positive Patients with an HIV Vaccine (Remune) - Article


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Lamivudine

3TC; Epivir; Epivir-HBV



Clinical Trial: Effectiveness of Treating HIV-Positive Patients with an HIV Vaccine (Remune)

This study is no longer recruiting patients.

Sponsored by: Agouron Pharmaceuticals
Information provided by: AIDS Clinical Trials Information Service

Purpose

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 Treatment or Intervention Phase
HIV Infections
 Drug: Lamivudine/Zidovudine
 Vaccine: HIV-1 Immunogen
 Drug: Nelfinavir mesylate
Phase III

MedlinePlus related topics:  AIDS

Study Type: Interventional
Study Design: Treatment, Double-Blind, Efficacy Study

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)

Further Study Details: 

Expected Total 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.

Eligibility

Ages Eligible for Study:  13 Years and above,  Genders Eligible for Study:  Both

Criteria

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.

Location Information


California
      Agouron Pharmaceuticals Inc, San Diego,  California,  92121,  United States

More Information

Study ID Numbers:  B009; AG1661-202
Record last reviewed:  August 2001
Last Updated:  October 13, 2004
Record first received:  March 21, 2000
ClinicalTrials.gov Identifier:  NCT00005002
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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November 18, 2008



Page Updated: June 1, 2005
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