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Study Evaluating Vaccine in Adults With HIV

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Sacramento, California, 95817 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
HIV Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00195234
Pfizer
Completed
Study Evaluating Vaccine in Adults With HIV

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[email protected]

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Study Evaluating Vaccine in Adults With HIV
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.

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
HIV Infections
Biological: HIV CTL MEP 1000 micrograms, 19 months per subject
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
February 2007
Not Provided

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00195234
6112K2-100
Not Provided
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
December 2007

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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