Recruiting

HIV Research

Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Code:

NCT00039689

Conditions

HIV

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

HIV

Study ID

NCT00039689

Start date

Jul 12, 2002

Status verified date

Mar 18, 2026

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

  • 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.

Study Design

Enrollment

750 participants

Anticipated

Interventions and Outcome Measures

Arms

HIV chronic infection

For example, an individual infected with HIV-1 for an indeterminate amount of time.

HIV early infection

For example, a negative HIV antibody immunoassay within 6 months of a positive HIV antibody assay and confirmatory test (as defined by current CDC criteria).

Primary outcome measure

  • To further investigate differences in the immunologic function of various lymphocyte subsets in PWH who are treated early after transmission of HIV and during the chronic phase of the disease. [ Time Frame: Throughout the study ]

Central Contacts and Locations

Central contacts

Kathleen R Gittens

(301) 435-8003kathleen.gittens@nih.gov

Susan L Moir, Ph.D.

(301) 402-4559sm221a@nih.gov

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

800-411-1222ccopr@nih.gov

More Information

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Last update posted

Sep 28, 2026

Last verified

Mar 18, 2026

Keywords

  • Cellular Immunity
  • Chronic HIV Infection
  • Antiretroviral Therapy
  • Primary HIV Infection
  • Humoral Immunity
  • Natural History
  • HIV Infection
  • Acute Infection
  • Treatment Naive

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-09. This information was provided to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID) on 2026-09-28. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.