The Use of Leukapheresis to Support HIV Pathogenesis Studies

NCT01161199 | Recruiting

• 1 other identifier: H52899-34904-01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Keywords

HIV; latent reservoir; functional cure; leukapheresis

Outcome Measures

Primary Outcomes (1)

• HIV DNA and RNA

  Baseline and 6-12 months

Study Arms (3)

Untreated non-controllers

Procedure: Leukapheresis

Elite controllers

Procedure: Leukapheresis

HAART-suppressed

Procedure: Leukapheresis

Interventions

Leukapheresis PROCEDURE

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; HAART-suppressed; Untreated non-controllers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HIV-infected patients on long-term antiretroviral therapy, untreated patients, and elite controllers will be studied.

You may qualify if:

• 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")

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

San Francisco General Hospital

San Francisco, California, 94110, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

CD4+ T cells Plasma

MeSH Terms

Interventions

Leukapheresis

Intervention Hierarchy (Ancestors)

Cytapheresis; Biological Therapy; Therapeutics; Blood Component Removal; Leukocyte Reduction Procedures; Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques

Study Officials

• Steven Deeks, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Steven Deeks, MD

CONTACT

415-476-4082; Steven.Deeks@ucsf.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2010
• First Posted: July 13, 2010
• Study Start: October 26, 2010
• Primary Completion (Estimated): July 1, 2033
• Study Completion (Estimated): July 1, 2033
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)