- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00195312
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-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.
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Berlin, Germany, 12157
-
Frankfurt, Germany, 60590
-
Hamburg, Germany, 20246
-
Hannover, Germany, 30625
-
Köln, Germany, 50937
-
München, Germany, 80336
-
-
-
-
-
Stockholm, Sweden, 118 23
-
-
-
-
Alabama
-
Birmingham, Alabama, United States, 35294
-
-
Colorado
-
Denver, Colorado, United States, 80262
-
-
Florida
-
Orlando, Florida, United States, 32803
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
-
-
Texas
-
Austin, Texas, United States, 78705
-
Dallas, Texas, United States, 75246
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Trial Manager, For Sweden, MedInfoNord@wyeth.com
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Anesthetics, Local
- Bupivacaine
Other Study ID Numbers
- 6120K1-100
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on HIV Infections
-
University of MinnesotaWithdrawnHIV Infections | HIV/AIDS | Hiv | AIDS | Aids/Hiv Problem | AIDS and InfectionsUnited States
-
University of California, San DiegoUniversity of California, Los Angeles; University of Southern California; California... and other collaboratorsCompleted
-
Gérond'ifRecruiting
-
University of California, DavisCompleted
-
University of California, San DiegoNational Center for Complementary and Integrative Health (NCCIH)CompletedHIV PositiveUnited States
-
University of ChicagoUniversity of Athens; National Development and Research Institutes, Inc.Completed
-
HIV Prevention Trials NetworkNational Institute on Drug Abuse (NIDA); National Institute of Allergy and...CompletedHIV PositiveIndonesia, Ukraine, Vietnam
-
University of ZimbabweCompleted
-
Florida International UniversityCompleted
-
Boston Children's HospitalNational Institute on Minority Health and Health Disparities (NIMHD)Completed
Clinical Trials on HIV-1 gag DNA (formulated with bupivacaine)
-
National Institute of Allergy and Infectious Diseases...CompletedHIV InfectionsUnited States, Thailand
-
National Institute of Allergy and Infectious Diseases...Completed
-
Merck Sharp & Dohme LLCCompleted
-
National Institute of Allergy and Infectious Diseases...AIDS Clinical Trials Group; Acute Infection and Early Disease Research ProgramCompletedHIV InfectionsUnited States, American Samoa, Australia
-
Merck Sharp & Dohme LLCTerminated
-
National Institute of Allergy and Infectious Diseases...HIV Vaccine Trials NetworkCompleted
-
National Institute of Allergy and Infectious Diseases...HIV Vaccine Trials NetworkCompleted
-
Merck Sharp & Dohme LLCHIV Vaccine Trials NetworkTerminatedHIV Infections | AIDS
-
National Institute of Allergy and Infectious Diseases...UnknownHIV InfectionsUnited States
-
National Institute of Allergy and Infectious Diseases...CompletedHIV InfectionsUnited States, Puerto Rico