Study Evaluating Vaccine in Adults With HIV

HIV Infections Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00195312
• Other study ID #: 6120K1-100
• Status: Terminated
• Phase: Phase 1
• First received: August 5, 2005
• Last updated: December 3, 2007
• Start date: August 2005
• Est. completion date: August 2007

Study information

• Verified date: December 2007
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical DevicesSweden: Medical Products AgencyGermany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 91
• Est. completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Biological:
• HIV-1 gag DNA (formulated with bupivacaine)

• IL-15 DNA (formulated with bupivacaine)

• IL-12 DNA (formulated with bupivacaine)

• Sodium chloride injection USP (0.9%)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Countries where clinical trial is conducted

United States,  Germany,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the safety and tolerability of intramuscular administration of HIV-1 gag DNA vaccine (total of three doses) in individuals on stable HAART
Primary	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
Primary	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