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RecruitingNot a traditional drug phaseobservationalRules rewrite

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

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).

Official registry: https://clinicaltrials.gov/study/NCT00039689 · National Institute of Allergy and Infectious Diseases (NIAID) · enrollment listed as 750

What this phase means

This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.

They plan to enroll about 750 people at Bethesda. Taking part typically means study visits and measurements plus check-ins.

Official title (unrewritten)

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

Primary outcome (registry wording): 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.

Who it is for (from inclusion criteria)

  • Ages 18 Years to 120 Years
  • Adult (18 years old or older) with HIV-1
  • Adequate venous access for research blood collection
  • 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)
  • Antiretroviral who have not tried this kind of treatment before, 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

Public study contact (from the registry)

Kathleen R Gittens

(301) 435-8003

kathleen.gittens@nih.gov

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

Related recruiting trials in this snapshot

RecruitingNot a traditional drug phaseBethesda, Maryland
Clinical and Immunologic Monitoring of Patients With Known or Suspected HIV Infection

This study will investigate HIV infection and associated conditions by monitoring infected patients. The study will also serve as a means for recruiting HIV-infected individuals to NIAIDs ongoing clinical and laboratory studies and supporting the institute s infectious disease training program by providing Infectious Disease fellows with ongoing training in the management of HIV infection.

NCT00789009 · Official ClinicalTrials.gov record · National Institute of Allergy and Infectious Diseases (NIAID)

FAQ about this NCT record

Is NCT00039689 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT00039689?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT00039689?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary