Study Evaluating Vaccine in Adults With HIV
This study has been completed.
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00195234
First received: September 12, 2005
Last updated: December 3, 2007
Last verified: December 2007
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Biological: HIV CTL MEP 1000 micrograms, 19 months per subject |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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. |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- To evaluate the subject immune system responds to the vaccinations. To evaluate RNA and protein patterns in the collected blood samples after vaccination.
| Estimated Enrollment: | 60 |
| Study Start Date: | December 2004 |
| Study Completion Date: | February 2007 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00195234
Locations
| 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, 75390-9103 | |
| Dallas, Texas, United States, 75246 | |
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
| Study Director: | Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00195234 History of Changes |
| Other Study ID Numbers: | 6112K2-100 |
| Study First Received: | September 12, 2005 |
| Last Updated: | December 3, 2007 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
|
HIV Treatment Experienced |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on May 16, 2013