Study Evaluating Vaccine in Adults With HIV

Completed · Phase 1

Conditions studied: HIV Infections

In brief

The purpose of this study is to learn whether the study vaccine and adjuvants (drugs that are used to help improve immune responses) have an acceptable safety profile in treating individuals with HIV. A second purpose of this study is to understand how the immune system responds to the study vaccine and adjuvants.

Key facts

Study ID

NCT00195234

Run by

Wyeth is now a wholly owned subsidiary of Pfizer

People needed

60

Starts

2004-12-01

Expected to finish

2007-02-01

Last updated by the study team

2007-12-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 years of age diagnosed with HIV and on stable HAART for a minimum of six months
• CD4 T-cell count greater than and equal to 350/mm3 at screening
• No reported CD4 T-cell count less than 350/mm3 at any time before screening
• Viral load less than 50 copies/mL at screening and no viral load greater than 400 copies/mL for a minimum of six months prior to screening

You may not qualify if…

• Any chronic symptomatic infection other than HIV
• Use of any prior HIV vaccine (prophylactic and/or therapeutic) within one year before or during screening
• Any malignancy that may require systemic therapy
• Use of any investigational treatment within six months before screening or planned during study enrollment, except for investigational retrovirals obtained through ACTG

Where it is running

• Study site — Sacramento, California, United States
• Study site — Denver, Colorado, United States
• Study site — Chicago, Illinois, United States
• Study site — New York, New York, United States
• Study site — Cleveland, Ohio, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Nashville, Tennessee, United States
• Study site — Austin, Texas, United States
• Study site — Dallas, Texas, United States
• Study site — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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