Effectiveness of Giving an HIV Vaccine (Remune) to HIV-Positive Patients Receiving an Anti-HIV Drug Combination

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

Studies have shown that inactivated, gp120-depleted whole virus immunogen (Remune) boosts immune responses to HIV. One response, lymphocyte proliferative response (LPR) to p24, is correlated with a low viral load in some patients with long-term non-progression of disease. This study examines whether administering Remune vaccine may generate new immune responses or boost existing responses to keep the level of virus in the blood low for a longer period of time than antiretroviral therapy alone. \[AS PER AMENDMENT 7/20/00: In a recent study using Remune, comparison of virologic failure and ti...

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Eligibility criteria

• • Inclusion Criteria
• Patients may be eligible for this study if they:
• • Are HIV-positive.
• • Have been on certain anti-HIV drugs for at least 3 months and intend to continue the same anti-HIV drugs unless they develop side effects to the drugs or their viral load rises above a certain level.
• • Have a viral load of less than 500 copies/ml for at least 3 months before entering the study.
• • Have a CD4 count of at least 300 cells/mm3.
• • Are at least 14 years old (consent of parent or guardian required if under 18).
• • Agree to practice barrier methods of birth control (such as condoms) while on the study and for 3 months after the study ends.
• * Patients may be eligible for the substudy if they:
• • Are at least 18 years old.
• • Have a plasma HIV viral load below 50 copies/ml.
• • Exclusion Criteria
• Patients will not be eligible for this study if they:
• • Are pregnant or breast-feeding.
• • Have had an infection requiring antibiotics, an outbreak of herpes simplex virus (HSV) or herpes zoster, or other illness or surgery within 30 days of study entry. (This study has been changed to exclude patients who have had an outbreak of HSV or herpes zoster or have had surgery within 30 days of study entry.)
• • Currently have any long-term infection other than HIV.
• • Have cancer that requires chemotherapy.
• • Have had lymph node irradiation.
• • Have ever received an HIV vaccine.
• • Have taken certain drugs affecting the immune system within 30 days of study entry.
• • Have taken hydroxyurea within 30 days of study entry.
• • Have received any vaccine within 30 days of study entry.
• * Patients will not be eligible for the substudy if they:
• • Have a history of allergies to egg proteins or neomycin, or a history of other serious allergic reactions.
• • Ever worked closely with canaries in a bird shop or breeding farm.