NCT01161199Recruiting
The Use of Leukapheresis to Support HIV Pathogenesis Studies
Source: ClinicalTrials.gov · Last updated 1 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 9 Jul 2010
- Start date
- 26 Oct 2010
- Primary completion date
- Jul 2033
- Lead sponsor
- University of California, San Francisco
- Diseases
- HIV
- NCT number
- NCT01161199
What you commit to
- Study type: Observational
- Planned participants: 100
- From 26 Oct 2010 to the primary completion date, Jul 2033
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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)
Lab values
- Platelets \< 50,000/mm3
- PTT \> 2x ULN
- INR \> 1.5
- Albumin \< 2.0 g/dL
- ALT \> 5x ULN
- AST \> 5x ULN
Other
- Biopsy-proven or clinical diagnosis of cirrhosis
- Weight \<120 lb
- High blood pressure \> 160/100
- Low blood pressure \< 100/70
- Pregnant
Who the study is looking for
- 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")
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| San Francisco General Hospital Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.