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

Completed · Phase 3

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00002359

Run by

The Immune Response Corporation

People needed

3000

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Ctr for Special Immunology — Irvine, California, 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 D.C., District of Columbia, United States
• Anderson Clinical Research — Washington D.C., District of Columbia, United States
• George Washington Univ Med Ctr — Washington D.C., District of Columbia, United States
• North Broward Hosp District — Fort Lauderdale, Florida, United States
• Ctr for Special Immunology — Miami Beach, Florida, United States
• The Coleman Institute — North Miami, Florida, United States
• Clinical Pharmacology Services — Tampa, Florida, United States
• AIDS Research Consortium of Atlanta — Atlanta, Georgia, United States
• Rush Med Ctr — Chicago, Illinois, United States
• Chicago AIDS Research Alliance — Chicago, Illinois, United States
• Ctr for Special Immunology — Chicago, Illinois, United States
• Community Hosp Indianapolis — Indianapolis, Indiana, United States
• UKSM-W Med Practice Association — Wichita, Kansas, United States
• Univ of Kentucky / Division of ID Research — Lexington, Kentucky, United States
• JSI Research and Training Institute — Boston, Massachusetts, United States
• Community Research Initiative of New England — Brookline Village, Massachusetts, United States
• Providence Mercy Hosp — Holyoke, Massachusetts, United States
• Wayne State Univ / WSU / DMC HIV / AIDS Program — Detroit, Michigan, United States
• Henry Ford Hosp / Infectious Diseases — Detroit, Michigan, United States
• Phoenix Body Positive — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.