100 Participants Needed

The Use of Leukapheresis to Support HIV Pathogenesis Studies

SD
Overseen BySteven Deeks, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of California, San Francisco
Must be taking: Antiretrovirals
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

SD

Steven Deeks, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

Inclusion Criteria

HIV seropositive
Able to give informed consent
Willing to undergo blood sampling and/or leukapheresis
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Leukapheresis Procedure

Participants undergo leukapheresis to obtain large numbers of CD4+ T cells for analysis

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the leukapheresis procedure

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Leukapheresis
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: Untreated non-controllersExperimental Treatment1 Intervention
Group II: HAART-suppressedExperimental Treatment1 Intervention
Group III: Elite controllersExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials
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Recruited
19,080,000+
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