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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).
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
Who the registry excludes
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
This study aims to provide long-term follow-up care of patients previously enrolled in a vaccine study that involved poxviral vectors. Vectors are sequences of genetic material that can be used to introduce specific genes into genetic makeup.
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.
The purpose of establishing a biorepository is to provide high quality specimens (serum, plasma, buffy coat and liver tissue) for future researchers who are studying the effects that fatty liver and viral diseases have on the liver.
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.