The Use of Leukapheresis to Support HIV Pathogenesis Studies

Sponsor

University of California, San Francisco (Other)

Overall Status

Recruiting

CT.gov ID

NCT01161199

Collaborator

(none)

100

Enrollment

Location

149

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV	Procedure: Leukapheresis

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

The Use of Leukapheresis to Support HIV Pathogenesis Studies

Actual Study Start Date :

Jul 1, 2010

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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

HAART-suppressed

Procedure: Leukapheresis

Outcome Measures

Primary Outcome Measures

HIV DNA and RNA [Baseline and 6-12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	San Francisco General Hospital	San Francisco	California	United States	94110

Sponsors and Collaborators

University of California, San Francisco

Investigators

Principal Investigator: Steven Deeks, MD, University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of California, San Francisco

ClinicalTrials.gov Identifier:

NCT01161199

Other Study ID Numbers:

H52899-34904-01

First Posted:

Jul 13, 2010

Last Update Posted:

May 19, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by University of California, San Francisco

Study Results

No Results Posted as of May 19, 2022