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A Multicenter, Double-Blind, Phase III, Adjuvant-Controlled Study of the Effect of 10 Units of HIV-1 Immunogen (Remune) Compared to Incomplete Freund's Adjuvant (IFA) Alone Every 12 Weeks on AIDS-Free Survival in Subjects With HIV Infection and CD4 T-Lymphocytes Between 300 and 549 Cells/microL Rega

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002359
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: June 1997

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002359 on ClinicalTrials.gov Archive Site
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A Multicenter, Double-Blind, Phase III, Adjuvant-Controlled Study of the Effect of 10 Units of HIV-1 Immunogen (Remune) Compared to Incomplete Freund's Adjuvant (IFA) Alone Every 12 Weeks on AIDS-Free Survival in Subjects With HIV Infection and CD4 T-Lymphocytes Between 300 and 549 Cells/microL Rega
A Multicenter, Double-Blind, Phase III, Adjuvant-Controlled Study of the Effect of 10 Units of HIV-1 Immunogen (Remune) Compared to Incomplete Freund's Adjuvant (IFA) Alone Every 12 Weeks on AIDS-Free Survival in Subjects With HIV Infection and CD4 T-Lymphocytes Between 300 and 549 Cells/microL Regardless of Concomitant HIV Therapies

To determine the effect of HIV-1 immunogen (Remune) on AIDS-free survival, defined as the time prior to development of an AIDS-defining condition or death.

Patients receive 10 units of HIV-1 immunogen in IFA or IFA alone every 12 weeks, then are followed for 104-148 weeks.

Interventional
Phase 3
Endpoint Classification: Efficacy Study
Masking: Double-Blind
Primary Purpose: Treatment
HIV Infections
Biological: HIV-1 Immunogen
Not Provided
Kahn JO, Cherng DW, Mayer K, Murray H, Lagakos S. Evaluation of HIV-1 immunogen, an immunologic modifier, administered to patients infected with HIV having 300 to 549 x 10(6)/L CD4 cell counts: A randomized controlled trial. JAMA. 2000 Nov 1;284(17):2193-202. Erratum in: JAMA 2001 May 2;285(17):2197.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3000
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Inclusion Criteria

Concurrent Medication:

Allowed:

  • Antiretrovirals if on a stable dose for at least the past 3 months.

Patients must have:

  • HIV-1 infection with CD4 count 300-549 cells/mm3.
  • No AIDS-defining condition.
  • Been on a stable dose of antiretroviral for the past 3 months, if taking antiretrovirals.

NOTE:

  • KS is permitted if not requiring systemic therapy.

Prior Medication:

Allowed:

  • Prior antiretrovirals.

Exclusion Criteria

Concurrent Medication:

Excluded:

  • Systemic chemotherapy for KS.
  • Treatment for malignancy other than basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.

Patients with the following prior conditions are excluded:

  • History of any illness that would interfere with study.
  • Acute infection requiring prescription therapy within the past month, other than genital herpes and oral or vaginal candidiasis.

Prior Medication:

Excluded:

  • Prior HIV-1 Immunogen. Unwilling to use effective safe sex practices. Active substance abuse.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002359
092, 806
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The Immune Response Corporation
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Not Provided
NIH AIDS Clinical Trials Information Service
June 1997

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP