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

Phase 3

Completed

• Conditions: HIV Infections

• Registration Number: NCT00002359
• Lead Sponsor: The Immune Response Corporation

Brief Summary

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.

Detailed Description

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

Study Timeline

• Status Verified: 1997-06
• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Last Update Submitted: 2005-06-23
• Last Update Posted: 2005-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (50)

Phoenix Body Positive; 🇺🇸 Phoenix, Arizona, United States

Ctr for Special Immunology; 🇺🇸 Chicago, Illinois, United States

Jeffrey Goodman Special Care Clinic; 🇺🇸 Los Angeles, California, United States

Kraus Med Partners; 🇺🇸 Los Angeles, California, United States

Cedars Sinai Med Ctr; 🇺🇸 Los Angeles, California, United States

AIDS Community Research Consortium; 🇺🇸 Redwood City, California, United States

Whitman Walker Clinic Inc; 🇺🇸 Washington, District of Columbia, United States

Anderson Clinical Research; 🇺🇸 Pittsburgh, Pennsylvania, United States

George Washington Univ Med Ctr; 🇺🇸 Washington, District of Columbia, United States

North Broward Hosp District; 🇺🇸 Fort Lauderdale, Florida, United States

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