Safety of Recombinant HIV Vaccines in HIV Infected Young Adults on Stable Therapy
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Treatment Experienced, HIV Therapeutic Vaccine
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Sites / Locations
- Children's Hospital Los Angeles NICHD CRS
- Usc La Nichd Crs
- Univ. of Colorado Denver NICHD CRS
- Chicago Children's CRS
- Univ. of Maryland Baltimore NICHD CRS
- Columbia IMPAACT CRS
- DUMC Ped. CRS
- St. Jude/UTHSC CRS
- Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
Arms of the Study
Arm 1
Experimental
1
All participants in this study will receive two injections of the rMVA-HIV vaccine and the rFPV-HIV vaccine