Status:
COMPLETED
Safety of Recombinant HIV Vaccines in HIV Infected Young Adults on Stable Therapy
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
HIV Infections
Eligibility:
All Genders
18-24 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the safety of two recombinant HIV vaccines in HIV infected young adults on stable anti-HIV therapy.
Detailed Description
By helping to control viral replication, HAART has dramatically improved the prognosis for HIV infected individuals. However, because of extensive side effects, some of which may be acute and life-thr...
Eligibility Criteria
Inclusion
- HIV-1 infected
- CD4 count of 350 cells/mm3 or greater
- If hepatitis B or C infected, infection must be chronic and stable
- Normal electrocardiogram (ECG)
- On stable HAART consisting of at least 3 different antiretrovirals from 2 different classes AND with a viral load of less than 100 copies/ml for at least 6 months prior to study entry
- Willing to use acceptable forms of contraception. Females enrolled in the study must use contraception for at least 21 days prior to first vaccination until the last study visit. Males enrolled in the study must use a condom from the first vaccination until one month after the last vaccination.
- Willing to follow all study requirements
- Available for follow-up for the duration of the study
Exclusion
- History of allergic reaction to eggs or egg products
- Known hypersensitivity to vaccine components
- Chemotherapy for active cancer in the 12 months prior to study entry
- Prior vaccination with any HIV-1 vaccine
- Prior vaccination against smallpox
- Prior vaccinia immunization
- Any immunization within 1 month of study screening
- History of or known active heart disease including myocardial infarction, angina pectoris, congestive heart failure, cardiomyopathy, pericarditis, stroke or transient ischemic attack, chest pain or shortness of breath with activity such as walking upstairs, mitral valve prolapse, or other heart conditions under a doctor's care
- Immunomodulatory agents, gamma globulin, or investigational agents within 6 months of study entry
- Systemic steroids, including nonprescription street steroids, within 6 months of study entry
- Documented or suspected serious bacterial infection, metabolic illness, cancer, or immediate life-threatening condition
- Any clinically significant diseases other than HIV infection or clinically significant findings during study screening that, in the investigator's opinion, may interfere with the study
- Current alcohol or drug abuse that, in the investigator's opinion, may interfere with the study
- Pregnancy or breastfeeding
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00107549
End Date
February 1 2009
Last Update
November 1 2021
Active Locations (9)
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1
Children's Hospital Los Angeles NICHD CRS
Los Angeles, California, United States, 90027
2
Usc La Nichd Crs
Los Angeles, California, United States, 90033
3
Univ. of Colorado Denver NICHD CRS
Aurora, Colorado, United States, 80218-1088
4
Chicago Children's CRS
Chicago, Illinois, United States, 60614