The Use of Leukapheresis to Support HIV Pathogenesis Studies

NCT ID: NCT01161199

Last Updated: 2025-04-03

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-10-26
• Study Completion Date: 2033-07-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Untreated non-controllers

Leukapheresis

Intervention Type: 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

Leukapheresis

Intervention Type: 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.

HAART-suppressed

Leukapheresis

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven Deeks, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

San Francisco General Hospital

San Francisco, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Steven Deeks, MD

Role: CONTACT

Steven.Deeks@ucsf.edu

415-476-4082 ext. 404

Facility Contacts

Steven Deeks, MD

Role: primary

Steven.Deeks@ucsf.edu

415-476-4082 ext. 404

Other Identifiers

H52899-34904-01

Identifier Type: -

Identifier Source: org_study_id