A Study of HIV-infected Subjects Initiating Anti-HIV Drugs for the First Time
Recruitment status was Recruiting
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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: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | A Study of HIV-Infected Subjects Initiating HAART for the First Time: A Qualifying Pre-Study for Dendritic Cell Immunization Study |
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 |
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
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 8,000
- 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| Contact: Sharon Lewis, RN,BSN, CCRN | 215-762-3251 | slewis@drexelmed.edu |
| Contact: David Downie, RN,BSN | 215-762-1665 | david.downie@drexelmed.edu |
| United States, Pennsylvania | |
| Drexel University College of Medicine | Recruiting |
| Philadelphia, Pennsylvania, United States, 19102 | |
| Principal Investigator: Jeffrey M Jacobson, MD | |
| Principal Investigator: | Jeffrey M Jacobson, MD | Drexel University College of Medicine |
More Information
No publications provided
| Responsible Party: | Jeffrey M. Jacobson MD, Drexel University College of Medicine |
| ClinicalTrials.gov Identifier: | NCT00595192 History of Changes |
| Other Study ID Numbers: | D001, RFP-NIH-NIAID-DAIDS-BAA-06-19 |
| Study First Received: | January 7, 2008 |
| Last Updated: | May 24, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Drexel University:
|
HIV treatment naïve |
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 |
ClinicalTrials.gov processed this record on May 22, 2013