Using leukapheresis to study HIV
The Use of Leukapheresis to Support HIV Pathogenesis Studies
This study is testing how a blood collection method called leukapheresis can help researchers understand HIV better and find ways to control the virus without ongoing treatment for people living with HIV.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT01161199 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on the use of leukapheresis to better understand HIV pathogenesis and explore potential strategies for achieving a functional cure. Participants include HIV-positive individuals who are either on stable antiretroviral therapy or untreated but have varying viral loads. The study aims to investigate the persistent challenges associated with HIV treatment, including long-term efficacy and the possibility of durable viral control without therapy. By analyzing blood samples collected through leukapheresis, researchers hope to gain insights into the latent reservoir of HIV and its implications for treatment.
Who should consider this trial
Good fit: Ideal candidates are HIV-positive individuals who are either on stable highly active antiretroviral therapy with an undetectable viral load or untreated individuals with specific viral load criteria.
Not a fit: Patients with severe blood disorders, anemia, or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved strategies for managing HIV and potentially achieving a functional cure.
How similar studies have performed: While the approach of using leukapheresis in HIV research is not widely established, there is ongoing interest in similar methodologies to address HIV pathogenesis.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
San Francisco, California
- San Francisco General Hospital — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Steven Deeks, MD — University of California, San Francisco
- Study coordinator: Steven Deeks, MD
- Email: Steven.Deeks@ucsf.edu
- Phone: 415-476-4082
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.