Collecting Blood Cells from HIV-Infected Patients for Research

Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants

This study is collecting blood cells from adults with HIV who are starting treatment to see how early therapy affects their immune system.

Quick facts

• Study type: Observational
• Enrollment: 750 (estimated)
• Ages: 18 Years to 120 Years
• Sex: All
• Sponsor: National Institutes of Health Clinical Center (CC) (nih)
• Locations: 1 site (Bethesda, Maryland)
• Trial ID: NCT00039689 on ClinicalTrials.gov

What this trial studies

This study aims to collect blood cells from adult patients infected with HIV, either in the acute or chronic stage, who are receiving early antiretroviral therapy. Participants will undergo leukapheresis, a procedure that separates white blood cells from the blood, allowing researchers to analyze immune responses and the effects of treatment on immune function. The study focuses on understanding how early treatment can preserve immune cell function and the dynamics of various immune cells in response to HIV. Blood samples will be collected multiple times to assess changes over time.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old who are HIV-infected, either in the early or chronic stages of the disease, and are willing to participate in follow-up visits.

Not a fit: Patients who are not HIV-infected or those who are not willing to undergo blood collection procedures may not benefit from this study.

Why it matters

Potential benefit: If successful, this research could lead to improved strategies for preserving immune function in HIV-infected patients and enhancing treatment outcomes.

How similar studies have performed: Other studies have shown promise in understanding immune responses in HIV-infected patients, making this approach a continuation of established research.

Eligibility criteria

* INCLUSION CRITERIA:

  1. Adult (18 years old or older) with HIV-1.
  2. Adequate venous access for research blood collection.
  3. Positive HIV antibody immunoassay and a positive confirmatory HIV test (as defined by current CDC criteria). Tests may be done in our clinic or by an outside provider. For individuals with suspected early HIV-1, the following additional criteria may be used: HIV-1 RNA levels of \>2,000 copies/ml with a negative result from an HIV antibody immunoassay.
  4. Willingness to be able to make follow up visits at least once in the next 4 months and prior to the initiation of antiretroviral therapy (ART).
  5. Blood pressure \< 180/100; pulse rate between 50-100 unless a lower pulse rate is considered normal for the volunteer.
  6. Adequate blood counts (hemoglobin greater than or equal to 9.0 g/dL, hematocrit greater than or equal to 28 percent, platelets greaterhan or equal to 50,000).
  7. Willingness and ability to give informed consent including consent for the storage of blood samples and genetic testing.
  8. Antiretroviral naive, no antiretroviral use in the last six months, or previously enrolled 02-I-0202 participants on whom there are samples stored in the repository.

     1. Participants who acquire HIV-1 while taking ART for pre-exposure prophylaxis will be eligible for enrollment as long as they meet diagnostic criteria for HIV positivity.
     2. Participants who enroll under another LIR apheresis protocol within the past three months and complete the apheresis within 4 weeks of starting ART will also be eligible for enrollment.
     3. Participants with limited (no more than 4 weeks before screening visit) recent use of ART may be eligible for study participation if, the opinion of the investigator, the ART usage will not impact the scientific validity of the protocol.

EXCLUSION CRITERIA:

1. Pregnant and / or breastfeeding.
2. Be currently abusing alcohol or other drugs that potentially could interfere with the participant s compliance or safety.
3. Have a condition which in the opinion of the investigators would make the participant ineligible for the study.

Where this trial is running

Bethesda, Maryland

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States (RECRUITING)

Study contacts

• Principal investigator: Susan L Moir, Ph.D. — National Institute of Allergy and Infectious Diseases (NIAID)
• Study coordinator: Kathleen R Gittens

Conditions: HIV, Cellular Immunity, Chronic HIV Infection, Antiretroviral Therapy, Primary HIV Infection, Humoral Immunity, Natural History, HIV Infection