- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01161199
The Use of Leukapheresis to Support HIV Pathogenesis Studies
Despite the dramatic improvements that have resulted from combination antiretroviral treatment, long-term efficacy, toxicity, cost, and the requirements for life-long adherence remain as formidable challenges. Also, there is emerging consensus that persistent HIV-associated disease occurs during long-term highly active antiretroviral therapy (HAART). This disease may be due to either direct drug-toxicity and/or persistent viral replication/production and/or persistent HIV-associated inflammation. Hence, strategies aimed at achieving complete viral eradication may be needed in order to fully restore health among HIV infected individuals. Even if complete eradication proves impossible-as most believe to be the case-a less rigorous but still desirable outcome might be achieving durable control of virus in the absence of therapy. That a "functional" cure is possible is well illustrated by those rare individuals who are able to durably control replication competent virus in the absence of therapy ("elite" controllers).
A more complete understanding of the relationship between inflammation and viral persistence is necessary before more rationale studies of HIV eradication can be designed. Also, a well validated high through-put virologic assay needs to be developed that can estimate the size of the latent reservoir. Since the level of replication competent virus in long-term treated patients (and in elite controllers) is very small (< 1% of CD4 cells harbor HIV), large numbers of CD4+ T cells most be obtained from study participants in order to routinely isolate and quantify virus persistence.
Study Overview
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Steven Deeks, MD
- Phone Number: 404 415-476-4082
- Email: Steven.Deeks@ucsf.edu
Study Locations
-
-
California
-
San Francisco, California, United States, 94110
- Recruiting
- San Francisco General Hospital
-
Contact:
- Steven Deeks, MD
- Phone Number: 404 415-476-4082
- Email: Steven.Deeks@ucsf.edu
-
Principal Investigator:
- Steven Deeks, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- HIV seropositive
- Able to give informed consent
- Willing to undergo blood sampling and/or leukapheresis
- Meeting one of the following criteria: (1) on stable highly active antiretroviral therapy (HAART) with a recent undetectable viral load (< 50 copies/mL) ("HAART suppressed"), (2) antiretroviral untreated with an undetectable viral load (< 50 copies/mL) ("elite" controllers) and (3) antiretroviral untreated with a detectable viral load (> 1000 copies/mL) ("non-controllers")
Exclusion Criteria:
- Known anemia (HIV+ males Hct<34; females Hct<32) or contraindication to donating blood
- Blood coagulation disorder (including bleeding tendency or problems in past with blood clots)
- Platelets < 50,000/mm3
- PTT > 2x ULN
- INR > 1.5
- Albumin < 2.0 g/dL
- ALT > 5x ULN
- AST > 5x ULN
- Biopsy-proven or clinical diagnosis of cirrhosis
- Weight <120 lb
- High blood pressure > 160/100
- Low blood pressure < 100/70
- Pregnant
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Untreated non-controllers
|
Blood will be taken by a needle placed in one arm and processed through a machine, which spins the blood so that the white blood cells will be separated out in the machine for purposes of this research and the rest of the blood will be returned through a needle in the other arm.
|
Elite controllers
|
Blood will be taken by a needle placed in one arm and processed through a machine, which spins the blood so that the white blood cells will be separated out in the machine for purposes of this research and the rest of the blood will be returned through a needle in the other arm.
|
HAART-suppressed
|
Blood will be taken by a needle placed in one arm and processed through a machine, which spins the blood so that the white blood cells will be separated out in the machine for purposes of this research and the rest of the blood will be returned through a needle in the other arm.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
HIV DNA and RNA
Time Frame: Baseline and 6-12 months
|
Baseline and 6-12 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Steven Deeks, MD, University of California, San Francisco
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- H52899-34904-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
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