Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT01161199
Recruitment Status : Recruiting
First Posted : July 13, 2010
Last Update Posted : May 4, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date July 9, 2010
First Posted Date July 13, 2010
Last Update Posted Date May 4, 2020
Study Start Date July 2010
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 14, 2015)
HIV DNA and RNA [ Time Frame: Baseline and 6-12 months ]
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Use of Leukapheresis to Support HIV Pathogenesis Studies
Official Title The Use of Leukapheresis to Support HIV Pathogenesis Studies
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
CD4+ T cells Plasma
Sampling Method Non-Probability Sample
Study Population HIV-infected patients on long-term antiretroviral therapy, untreated patients, and elite controllers will be studied.
Condition HIV
Intervention 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.
Study Groups/Cohorts
  • Untreated non-controllers
    Intervention: Procedure: Leukapheresis
  • Elite controllers
    Intervention: Procedure: Leukapheresis
  • HAART-suppressed
    Intervention: Procedure: Leukapheresis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 14, 2015)
100
Original Estimated Enrollment
 (submitted: July 12, 2010)
75
Estimated Study Completion Date July 2020
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Steven Deeks, MD 415-476-4082 ext 404 Steven.Deeks@ucsf.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01161199
Other Study ID Numbers H52899-34904-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of California, San Francisco
Study Sponsor University of California, San Francisco
Collaborators Not Provided
Investigators
Principal Investigator: Steven Deeks, MD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date April 2020