RECRUITING

The Use of Leukapheresis to Support HIV Pathogenesis Studies

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The Use of Leukapheresis to Support HIV Pathogenesis Studies

Quick Facts

Study Start:2010-10-26
Study Completion:2033-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT01161199

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * HIV seropositive
  2. * Able to give informed consent
  3. * Willing to undergo blood sampling and/or leukapheresis
  4. * 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")
  1. * Known anemia (HIV+ males Hct\<34; females Hct\<32) or contraindication to donating blood
  2. * Blood coagulation disorder (including bleeding tendency or problems in past with blood clots)
  3. * Platelets \< 50,000/mm3
  4. * PTT \> 2x ULN
  5. * INR \> 1.5
  6. * Albumin \< 2.0 g/dL
  7. * ALT \> 5x ULN
  8. * AST \> 5x ULN
  9. * Biopsy-proven or clinical diagnosis of cirrhosis
  10. * Weight \<120 lb
  11. * High blood pressure \> 160/100
  12. * Low blood pressure \< 100/70
  13. * Pregnant

Contacts and Locations

Study Contact

Steven Deeks, MD
CONTACT
415-476-4082
Steven.Deeks@ucsf.edu

Principal Investigator

Steven Deeks, MD
PRINCIPAL_INVESTIGATOR
University of California, San Francisco

Study Locations (Sites)

San Francisco General Hospital
San Francisco, California, 94110
United States

Collaborators and Investigators

Sponsor: University of California, San Francisco

  • Steven Deeks, MD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2010-10-26
Study Completion Date2033-07

Study Record Updates

Study Start Date2010-10-26
Study Completion Date2033-07

Terms related to this study

Keywords Provided by Researchers

  • HIV
  • latent reservoir
  • functional cure
  • leukapheresis

Additional Relevant MeSH Terms

  • HIV