The Use of Leukapheresis to Support HIV Pathogenesis Studies

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by University of California, San Francisco
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01161199
First received: July 9, 2010
Last updated: October 17, 2013
Last verified: October 2013
  Purpose

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 Intervention
HIV
Procedure: Leukapheresis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Use of Leukapheresis to Support HIV Pathogenesis Studies

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • HIV DNA and RNA [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

CD4+ T cells Plasma


Estimated Enrollment: 75
Study Start Date: July 2010
Estimated Study Completion Date: July 2020
Estimated Primary Completion Date: July 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01161199

Contacts
Contact: Hiroyu Hatano, MD 415-476-4082 ext 122 hhatano@php.ucsf.edu
Contact: Kara Harvill, BA 415-476-4082 ext 341 harvillk@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: Kara Harvill, BA    415-476-4082 ext 341    harvillk@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

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01161199     History of Changes
Other Study ID Numbers: H52899-34904-01
Study First Received: July 9, 2010
Last Updated: October 17, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 21, 2014