Safety of and Immune Response to Polyvalent HIV-1 Vaccine in HIV Uninfected Adults

Status unconfirmed · Phase 1

Conditions studied: HIV Infections

In brief

This study will evaluate the safety of and immune response to a new HIV vaccine. The vaccine in this trial uses pieces of HIV DNA and HIV proteins. The vaccine itself cannot cause HIV infection or AIDS.

Key facts

Study ID

NCT00061243

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

36

Starts

2004-04-01

Expected to finish

2010-04-01

Last updated by the study team

2008-09-26

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• HIV uninfected
• Good general health as determined by medical history, physical examination, vital signs, and clinical laboratory measurements
• Body Mass Index (BMI) =< 32
• Hepatitis B surface antigen negative
• Anti-hepatitis C virus antibody (anti-HCV) negative or negative HCV PCR if anti-HCV is positive
• Low risk for HIV exposure
• No co-existent endocrine conditions
• No evidence of hepatic insufficiency, significant renal insufficiency, or proteinuria
• Acceptable methods of contraception
• Anticipated availability for the planned follow-up period of one year

You may not qualify if…

• Certain medications during the 2 weeks prior to study entry
• Donation of a unit of blood within 2 months prior to study entry
• Participation in a study of investigational or marketed drugs within 1 month prior to study entry
• Blood transfusion within 6 months prior to study entry
• Pregnant, breastfeeding, or planning pregnancy during the study period
• History of significant adverse reaction to any vaccine
• Prior receipt of any experimental HIV vaccine
• Morbid obesity (> 195% of ideal body weight)
• Hypertension (patients may be taking concomitant antihypertensive medication during the study if approved by study officials)
• History of chronic medical illness, malignancy, or autoimmune disorder
• History of immunodeficiency or treatment with immunosuppressive medications
• History of organ transplant
• Medical or psychiatric obstacle to compliance with protocol
• Significant urine concentration of any drug that could interfere with the study

Where it is running

• University of Massachusetts School of Medicine — Worcester, Massachusetts, United States

Full record on ClinicalTrials.gov

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