Safety of Recombinant HIV Vaccines in HIV Infected Young Adults on Stable Therapy

Completed · Phase 1

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00107549

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

20

Expected to finish

2009-02-01

Last updated by the study team

2021-11-01

Who can join

Age: 18 and older, up to 24. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Children's Hospital Los Angeles NICHD CRS — Los Angeles, California, United States
• Usc La Nichd Crs — Los Angeles, California, United States
• Univ. of Colorado Denver NICHD CRS — Aurora, Colorado, United States
• Chicago Children's CRS — Chicago, Illinois, United States
• Univ. of Maryland Baltimore NICHD CRS — Baltimore, Maryland, United States
• Columbia IMPAACT CRS — New York, New York, United States
• DUMC Ped. CRS — Durham, North Carolina, United States
• St. Jude/UTHSC CRS — Memphis, Tennessee, United States
• Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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