Study Evaluating Vaccine in Adults With HIV

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00195234
• Collaborator: (none)
• Enrollment: 60
• Locations: 10
• Duration (Months): 26
• Patients Per Site: 6
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

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 Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• 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.
• Study Start Date: Dec 1, 2004
• Actual Study Completion Date: Feb 1, 2007

Outcome Measures

Primary Outcome Measures

1. 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

1. To evaluate the subject immune system responds to the vaccinations. To evaluate RNA and protein patterns in the collected blood samples after vaccination. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1		Sacramento	California	United States	95817
2		Denver	Colorado	United States	80262
3		Chicago	Illinois	United States	60612
4		New York	New York	United States	10003
5		Cleveland	Ohio	United States	44106-5083
6		Philadelphia	Pennsylvania	United States	19104
7		Nashville	Tennessee	United States	37232-2582
8		Austin	Texas	United States	78705
9		Dallas	Texas	United States	75246
10		Dallas	Texas	United States	75390-9103

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00195234
• Other Study ID Numbers: 6112K2-100
• First Posted: Sep 19, 2005
• Last Update Posted: Dec 5, 2007
• Last Verified: Dec 1, 2007

• Keywords provided by , ,: HIV; Treatment Experienced
• Additional relevant MeSH terms: HIV Infections

Study Results

No Results Posted as of Dec 5, 2007