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
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ClinicalTrials.gov Identifier: NCT00002359 |
Recruitment Status
:
Completed
First Posted
: August 31, 2001
Last Update Posted
: June 24, 2005
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Biological: HIV-1 Immunogen | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 3000 participants |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | 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 |


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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002359

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: | NCT00002359 History of Changes |
Other Study ID Numbers: |
092 806 |
First Posted: | August 31, 2001 Key Record Dates |
Last Update Posted: | June 24, 2005 |
Last Verified: | June 1997 |
Keywords provided by NIH AIDS Clinical Trials Information Service:
Vaccines, Synthetic Viral Vaccines HIV-1 |
AIDS-Related Complex AIDS Vaccines Salk HIV Immunogen |
Additional relevant MeSH terms:
Infection Communicable Diseases HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral |
Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Freund's Adjuvant Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs |