Clinical trial NCT01161199: The Use of Leukapheresis to Support HIV Pathogenesis Studies
Official title: The Use of Leukapheresis to Support HIV Pathogenesis Studies
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HIV
Keywords: HIV
latent reservoir
functional cure
leukapheresis
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2010-07-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV-infected patients on long-term antiretroviral therapy, untreated patients, and elite controllers will be studied.

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.


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

Primary outcomes:
measure: HIV DNA and RNA
timeFrame: Baseline and 6-12 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco General Hospital
state: California
Study officials:
affiliation: University of California, San Francisco
name: Steven Deeks, MD
role: PRINCIPAL_INVESTIGATOR
References: