A Study of HIV-Infected Subjects Initiating Anti-HIV Drugs for the First Time

This study is currently recruiting participants.

Verified by Drexel University, February 2009

First Received: January 7, 2008 Last Updated: April 6, 2009 History of Changes

Sponsor:	Drexel University College of Medicine
Collaborators:	National Institutes of Health (NIH) Argos Therapeutics
Information provided by:	Drexel University
ClinicalTrials.gov Identifier:	NCT00595192

Purpose

Subjects who are ready to start anti-retroviral therapy (ART) will be screened to see if they are eligible for this study. If interested, patient will enroll in this study the same day they are going to start their ART. A blood sample will be obtained that day before they start ART. This sample will be frozen and sent to a special lab at Argos Therapeutics to be stored until the subject's personalized vaccine can be created. We are not certain that a vaccine can be created for everyone. Subjects will be under no obligation to receive the vaccine if it is made.

Condition
HIV Infections

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	A Study of HIV-Infected Subjects Initiating HAART for the First Time: A Qualifying Pre-Study for Dendritic Cell Immunization Study

Resource links provided by NLM:

MedlinePlus related topics: AIDS

U.S. FDA Resources

Further study details as provided by Drexel University:

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

A frozen plasma sample will be sent to Argos Therapeutics to be stored for possible later use for an autologous dendritic cell HIV-RNA loaded immunization study.

Estimated Enrollment:	35
Study Start Date:	January 2008
Estimated Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

HIV patients ready to start HIV Medications for the First Time or following a twelve week break in regimen, will be enrolled into study for observation on the same day that they are going to start HIV medications

Criteria

Inclusion Criteria:

Patients have never taken ARVs,have had a minimum of a twelve week break in regimen,or only as post exposure prophylaxis or for less that 14 days.
Viral load at least 15,000
CD4 count at least 200 within 30 days of study enrollment

Exclusion Criteria:

Prior use of HIV Vaccine
Hepatitis B surface antibody positive
Hepatitis C positive
Positive syphilis
History of or evidence of severe illness/malignancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00595192

Contacts

Contact: Sharon Lewis, RN,BSN, CCRN	215-762-3251	slewis@drexelmed.edu
Contact: Sara Skinner, RN,BSN	215-762-1665	sara.skinner@drexelmed.edu

Locations

United States, Pennsylvania
Drexel University College of Medicine	Recruiting
Philadelphia, Pennsylvania, United States, 19102
Principal Investigator: Jeffrey M Jacobson, MD

Sponsors and Collaborators

Drexel University College of Medicine

National Institutes of Health (NIH)

Argos Therapeutics

Investigators

Principal Investigator:

Jeffrey M Jacobson, MD

Drexel University College of Medicine

More Information

No publications provided

Responsible Party:	Drexel University College of Medicine ( Jeffrey M. Jacobson MD )
Study ID Numbers:	D001, RFP-NIH-NIAID-DAIDS-BAA-06-19
Study First Received:	January 7, 2008
Last Updated:	April 6, 2009
ClinicalTrials.gov Identifier:	NCT00595192 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Drexel University:

HIV
treatment naïve

Additional relevant MeSH terms:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on February 08, 2010