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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
The Immune Response Corporation
Patients receive 10 units of HIV-1 immunogen in IFA or IFA alone every 12 weeks, then are followed for 104-148 weeks.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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.
Clareo Health | 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
