NCT00039689 · National Institute of Allergy and Infectious Diseases (NIAID)
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
What this study is about
There is evidence that early and aggressive treatment with antiretroviral drugs can prevent the loss of immune cell function that accompanies HIV infection.
View original scientific description
There is evidence that early and aggressive treatment with antiretroviral drugs can prevent the loss of immune cell function that accompanies HIV infection. This study will use leukapheresis (drawing blood, separating out the white cells and returning the blood to the patient) to obtain blood cells from HIV-infected patients in either the acute or chronic stage of infection who are being treated with early highly active antiretroviral therapy (HAART). Leukapheresis is necessary to obtain enough cells to delineate the response of B cells to CD4+ T cell help, the CD8 factors associated with suppression of viral replication and normalization of immune function, and natural killer function relative to HIV disease. Study participants will be adult (older than 18 years) HIV primary or acutely affected patients (those with a history of exposure to HIV but not yet showing chronic symptoms of HIV disease) and HIV chronically infected patients (those infected with HIV for longer than 12 months or showing other symptoms of HIV disease) who are not receiving HAART at the beginning of the study. The study seeks to enroll 30 primary and 30 chronic patients. Pregnant women will not be enrolled in the study; women who become pregnant will be dropped from the study. Leukapheresis will be performed on each patient before HAART therapy begins and then three times a year. Each session will take between 1 and 3 hours. This longitudinal study will enable researchers to examine the function of certain B cells, natural killer cells, and CD8+ T cells in people who do not have chronic HIV disease and in those who do have the disease and are treated with HAART.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Adult (18 years old or older) with HIV-1.
- Adequate venous access for research blood collection.
- 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.
- 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).
- Blood pressure \< 180/100; pulse rate between 50-100 unless a lower pulse rate is considered normal for the volunteer.
- 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).
- Willingness and ability to give informed consent including consent for the storage of blood samples and genetic testing.
- 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.
- 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.
- 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.
- 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
- Pregnant and / or breastfeeding.
- Be currently abusing alcohol or other drugs that potentially could interfere with the participant s compliance or safety.
- Have a condition which in the opinion of the investigators would make the participant ineligible for the study.
Where
- Bethesda, Maryland
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 29, 2026 · Source of record for eligibility and locations