Study Evaluating Vaccine in Adults With HIV
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00195234|
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : December 5, 2007
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.
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Biological: HIV CTL MEP 1000 micrograms, 19 months per subject||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Phase 1 Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of an HIV CTL Multi-Epitope Peptide Vaccine Formulated With RC529-SE and GM-CSF Given to HIV-1 Positive Adults on Stable HAART.|
|Study Start Date :||December 2004|
|Actual Study Completion Date :||February 2007|
- To evaluate the safety and tolerability of the HIV CTL MEP vaccine formulated with adjuvants, administered by intramuscular (IM) injection to HIV Pos adults receiving stable HAART. Subjects will receive vaccinations at months 0, 1, 3, and 6.
- To evaluate the subject immune system responds to the vaccinations. To evaluate RNA and protein patterns in the collected blood samples after vaccination.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00195234
|United States, California|
|Sacramento, California, United States, 95817|
|United States, Colorado|
|Denver, Colorado, United States, 80262|
|United States, Illinois|
|Chicago, Illinois, United States, 60612|
|United States, New York|
|New York, New York, United States, 10003|
|United States, Ohio|
|Cleveland, Ohio, United States, 44106-5083|
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37232-2582|
|United States, Texas|
|Austin, Texas, United States, 78705|
|Dallas, Texas, United States, 75246|
|Dallas, Texas, United States, 75390-9103|
|Study Director:||Medical Monitor||Wyeth is now a wholly owned subsidiary of Pfizer|