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The Use of Leukapheresis to Support HIV Pathogenesis Studies

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ClinicalTrials.gov Identifier: NCT01161199
Recruitment Status : Recruiting
First Posted : July 13, 2010
Last Update Posted : August 18, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.


Condition or disease Intervention/treatment
HIV Procedure: Leukapheresis

Study Design

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Use of Leukapheresis to Support HIV Pathogenesis Studies
Study Start Date : July 2010
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Untreated non-controllers Procedure: Leukapheresis
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 Procedure: Leukapheresis
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 Procedure: Leukapheresis
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.


Outcome Measures

Primary Outcome Measures :
  1. HIV DNA and RNA [ Time Frame: Baseline and 6-12 months ]

Biospecimen Retention:   Samples With DNA
CD4+ T cells Plasma

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
HIV-infected patients on long-term antiretroviral therapy, untreated patients, and elite controllers will be studied.
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01161199


Contacts
Contact: Hiroyu Hatano, MD 415-476-4082 ext 122 hhatano@php.ucsf.edu
Contact: Steven G. Deeks, MD 415-476-4082 ext 404 sdeeks@php.ucsf.edu

Locations
United States, California
San Francisco General Hospital Recruiting
San Francisco, California, United States, 94110
Contact: Hiroyu Hatano, MD    415-476-4082 ext 122    hhatano@php.ucsf.edu   
Contact: Steven G. Deeks, MD    415-476-4082 ext 404    sdeeks@php.ucsf.edu   
Principal Investigator: Hiroyu Hatano, MD         
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Hiroyu Hatano, MD University of California, San Francisco
More Information

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01161199     History of Changes
Other Study ID Numbers: H52899-34904-01
First Posted: July 13, 2010    Key Record Dates
Last Update Posted: August 18, 2015
Last Verified: August 2015

Keywords provided by University of California, San Francisco:
HIV
latent reservoir
functional cure
leukapheresis