Study Evaluating Vaccine in Adults With HIV
This study has been terminated.
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
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
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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:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
Drug Information available for:
Sodium chloride
Deoxyribonucleic acid
Bupivacaine hydrochloride
Bupivacaine
Interleukin-12
U.S. FDA Resources
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
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 May 19, 2013