The Use of Leukapheresis to Support HIV Pathogenesis Studies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01161199
Recruitment Status : Recruiting
First Posted : July 13, 2010
Last Update Posted : November 8, 2018
Information provided by (Responsible Party):
University of California, San Francisco

July 9, 2010
July 13, 2010
November 8, 2018
July 2010
July 2020   (Final data collection date for primary outcome measure)
HIV DNA and RNA [ Time Frame: Baseline and 6-12 months ]
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Complete list of historical versions of study NCT01161199 on Archive Site
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The Use of Leukapheresis to Support HIV Pathogenesis Studies
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.

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Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples With DNA
CD4+ T cells Plasma
Non-Probability Sample
HIV-infected patients on long-term antiretroviral therapy, untreated patients, and elite controllers will be studied.
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.
  • Untreated non-controllers
    Intervention: Procedure: Leukapheresis
  • Elite controllers
    Intervention: Procedure: Leukapheresis
  • HAART-suppressed
    Intervention: Procedure: Leukapheresis
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
July 2020
July 2020   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact: Hiroyu Hatano, MD 415-476-4082 ext 122
Contact: Steven G. Deeks, MD 415-476-4082 ext 404
United States
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University of California, San Francisco
University of California, San Francisco
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Principal Investigator: Hiroyu Hatano, MD University of California, San Francisco
University of California, San Francisco
November 2018