NCT00195312

Brief Summary

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P75+ for phase_1 hiv-infections

Timeline
Completed

Started Aug 2005

Geographic Reach
3 countries

13 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

August 5, 2005

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

December 5, 2007

Status Verified

December 1, 2007

First QC Date

August 5, 2005

Last Update Submit

December 3, 2007

Conditions

HIV Infections

Keywords

HIVVaccineTreatment Experienced

Outcome Measures

Primary Outcomes (3)

  • 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

Interventions

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%)BIOLOGICAL

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Unknown Facility

Birmingham, Alabama, 35294, United States

Location

Unknown Facility

Denver, Colorado, 80262, United States

Location

Unknown Facility

Orlando, Florida, 32803, United States

Location

Unknown Facility

Boston, Massachusetts, 02215, United States

Location

Unknown Facility

Austin, Texas, 78705, United States

Location

Unknown Facility

Dallas, Texas, 75246, United States

Location

Unknown Facility

Berlin, 12157, Germany

Location

Unknown Facility

Cologne, 50937, Germany

Location

Unknown Facility

Frankfurt, 60590, Germany

Location

Unknown Facility

Hamburg, 20246, Germany

Location

Unknown Facility

Hanover, 30625, Germany

Location

Unknown Facility

München, 80336, Germany

Location

Unknown Facility

Stockholm, 118 23, Sweden

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Medical Monitor, MD

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

  • Trial Manager

    For Germany, MedinfoDEU@wyeth.com

    PRINCIPAL INVESTIGATOR

  • Trial Manager

    For Sweden, MedInfoNord@wyeth.com

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 5, 2005

First Posted

September 19, 2005

Study Start

August 1, 2005

Study Completion

August 1, 2007

Last Updated

December 5, 2007

Record last verified: 2007-12

Locations

DE(6)US(6)SE(1)