Study Evaluating Vaccine in Adults With HIV

Stopped early · Phase 1

Conditions studied: HIV Infections

In brief

The main purpose of this study is to learn whether the study vaccine and the adjuvants(drugs that are used to help immune response) have an acceptable safety profile in treating individuals with HIV. A second purpose for this study is to understand how your immune system responds to the study vaccine with the adjuvants. Understanding these differences could be useful in several ways. First, it might help identify people whose disease is likely to respond to the study vaccine with the study adjuvants. Second, the information might be useful in developing other treatments for people whose disease does not respond to the study vaccine with the adjuvants.

Key facts

Study ID

NCT00195312

Run by

Wyeth is now a wholly owned subsidiary of Pfizer

People needed

91

Starts

2005-08-01

Expected to finish

2007-08-01

Last updated by the study team

2007-12-05

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must be HIV positive.
• Receiving stable HAART for a minimum of 6 consecutive months immediately before screening.
• CD4 T-cell count greater than 350 mm cubed/mL at time of screening and no reported CD4 T-cell count less than 250 mm cubed/mL at any time before screening.
• Other Inclusions Apply

You may not qualify if…

• Any chronic symptomatic infection other than HIV.
• History of diagnosed autoimmune disease (currently active or under control).
• Use of any prior HIV vaccine (prophylactic and/or therapeutic) within one year before or during screening (documented, unblinded placebo recipients from previous clinical trials may participate without this time restriction).
• Other Exclusions Apply

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Denver, Colorado, United States
• Study site — Orlando, Florida, United States
• Study site — Boston, Massachusetts, United States
• Study site — Austin, Texas, United States
• Study site — Dallas, Texas, United States
• Study site — Berlin, Germany
• Study site — Cologne, Germany
• Study site — Frankfurt, Germany
• Study site — Hamburg, Germany
• Study site — Hanover, Germany
• Study site — München, Germany
• Study site — Stockholm, Sweden

Full record on ClinicalTrials.gov

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