Study Evaluating Vaccine in Adults With HIV

This study has been terminated.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00195312
First received: August 5, 2005
Last updated: December 3, 2007
Last verified: December 2007
  Purpose

The main purpose of this study is to learn whether the study vaccine and the adjuvants(drugs that are used to help immune response) have an acceptable safety profile in treating individuals with HIV.

A second purpose for this study is to understand how your immune system responds to the study vaccine with the adjuvants. Understanding these differences could be useful in several ways. First, it might help identify people whose disease is likely to respond to the study vaccine with the study adjuvants. Second, the information might be useful in developing other treatments for people whose disease does not respond to the study vaccine with the adjuvants.


Condition Intervention Phase
HIV Infections
Biological: HIV-1 gag DNA (formulated with bupivacaine)
Biological: IL-15 DNA (formulated with bupivacaine)
Biological: IL-12 DNA (formulated with bupivacaine)
Biological: Sodium chloride injection USP (0.9%)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy 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-1 Gag DNA Vaccine Administered Alone or With Escalating Doses of IL-12 DNA or IL-15 DNA Molecular Adjuvants to HIV-1 Positive Adults Receiving Stable HAART.

Resource links provided by NLM:


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 intramuscular administration of HIV-1 gag DNA vaccine (total of three doses) in individuals on stable HAART
  • intramuscular administration of HIV-1 gag DNA vaccine when administered with increasing dosage levels of IL-12 DNA following each vaccine dose (total of three doses) in individuals on stable HAART
  • intramuscular administration of HIV-1 gag DNA vaccine when administered with increasing dosage levels of IL-15 DNA following each vaccine dose (total of three doses) in individuals on stable HAART

Estimated Enrollment: 91
Study Start Date: August 2005
Study Completion Date: August 2007
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must be HIV positive.
  • Receiving stable HAART for a minimum of 6 consecutive months immediately before screening.
  • CD4 T-cell count greater than 350 mm cubed/mL at time of screening and no reported CD4 T-cell count less than 250 mm cubed/mL at any time before screening.

Other Inclusions Apply

Exclusion Criteria:

  • Any chronic symptomatic infection other than HIV.
  • History of diagnosed autoimmune disease (currently active or under control).
  • Use of any prior HIV vaccine (prophylactic and/or therapeutic) within one year before or during screening (documented, unblinded placebo recipients from previous clinical trials may participate without this time restriction).

Other Exclusions Apply

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00195312

Locations
United States, Alabama
Birmingham, Alabama, United States, 35294
United States, Colorado
Denver, Colorado, United States, 80262
United States, Florida
Orlando, Florida, United States, 32803
United States, Massachusetts
Boston, Massachusetts, United States, 02215
United States, Texas
Austin, Texas, United States, 78705
Dallas, Texas, United States, 75246
Germany
Berlin, Germany, 12157
Frankfurt, Germany, 60590
Hamburg, Germany, 20246
Hannover, Germany, 30625
Köln, Germany, 50937
München, Germany, 80336
Sweden
Stockholm, Sweden, 118 23
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor, MD Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Germany, MedinfoDEU@wyeth.com
Principal Investigator: Trial Manager For Sweden, MedInfoNord@wyeth.com
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00195312     History of Changes
Other Study ID Numbers: 6120K1-100
Study First Received: August 5, 2005
Last Updated: December 3, 2007
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Sweden: Medical Products Agency
Germany: Paul-Ehrlich-Institut

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
HIV
Vaccine
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
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014