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HIV InfectionNCT00001650

Use of Bromodeoxyuridine to Study White Blood Cell Replication and Survival in HIV-Infected Patients

An observational study of HIV Infection and Acquired Immunodeficiency Syndrome, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will examine how quickly white blood cells called CD4 lymphocytes reproduce and how long they live in people infected with HIV. It will do this using bromodeoxyuridine (BrDU), a compound that is structurally similar to thymidine, one of the building blocks of DNA. Read more about this study

Who is it for?
Ages 18 years and older
How many people
56 participants
Where
1 siteUnited States
Study dates
19 Sep 1997to 13 May 2011
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 years or older.
  • Documented HIV infection (ELISA/Western blot positive or, for acute seroconverters, PCR positive).
  • Able to provide informed consent and willing to comply with study requirements and clinic policies.
  • Negative urine or serum pregnancy test (for women of childbearing potential). In addition, women of childbearing potential must agree to practice abstinence or use two methods of birth control / contraception for 4 weeks prior to and 2 weeks after each BrDU infusion. Similarly, all men must agree to practice abstinence or use a condom when engaging in intercourse during the same time period.
  • Hemoglobin greater than 9 mg/dl; platelets greater than 50,000/mm(3); neutrophils greater than 750 cells/mm(3).
  • AST/ALT less than 300 IU/ml.
  • Less than Grade 2 level toxicity for other laboratory parameters.

Who cannot join

  • Active substance abuse or prior history of substance abuse which may interfere with protocol compliance.
  • Psychiatric illness or disturbance which, in the assessment of the protocol team, may affect safety or compliance.
  • Significant underlying cardiac, pulmonary, renal, gastrointestinal, rheumatologic or CNS disease as detectable on routine history, physical exam, or screening laboratory studies.
  • Pregnancy or breast-feeding.
  • Ongoing therapy with topical or systemic 5-fluorouracil.
  • Willingness to allow stored samples to be used for future studies of HIV infections and immunological function, and willingness to have HLA typing performed.
Show all 15Show fewer
  • Patients who are virologic responders and immunologic non-responders (10-15 patients):
  • Plasma HIV less than 500 copies/ml by bDNA or RT-PCR for 1 year while receiving HAART, which includes at a minimum 3 antiretroviral drugs, at least one of which is a protease inhibitor or non-nucleoside reverse transcriptase inhibitor, and plasma HIV less than 50 copies /ml by the bDNA assay, performed at the NIH, within the 4 weeks prior to enrollment;
  • CD4 count less than 300 cells/mm(3) on 2 occasions at least one week apart, with no documented CD4 count greater than 350 cells/mm(3) during the prior 6 months;
  • No ongoing opportunistic infection or malignancy.
  • Patients who are virologic and immunologic responders (10-15 patients, matched if possible to study group for age (+/- 5 years) and duration of HAART therapy (+/- 6 months):
  • Plasma HIV less than 500 copies/ml by bDNA or RT-PCR for 1 year while receiving HAART, which includes at a minimum 3 antiretroviral drugs, at least one of which is a protease inhibitor or non-nucleoside reverse transcriptase inhibitor, and plasma HIV less than 50 copies/ml by the bDNA assay, performed at the NIH, within the 4 weeks prior to enrollment;
  • CD4 count greater than 350 cells/mm(3) on 2 occasions at least one week apart; CD4 count prior to the initiation of HAART therapy documented to be less than 300 cells/mm(3);
  • No ongoing opportunistic infection or malignancy.
  • For all patients: Willingness to have a CT scan of the thymus, to be performed under protocol 95-I-0027.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: Studies of Lymphocyte Kinetics Using Bromodeoxyuridine

This study will examine how quickly white blood cells called CD4 lymphocytes reproduce and how long they live in people infected with HIV. It will do this using bromodeoxyuridine (BrDU), a compound that is structurally similar to thymidine, one of the building blocks of DNA. BrDU gets incorporated into DNA instead of thymidine, but it can only get into cells that are replicating. Therefore, measuring the proportion of cells with BrDU indicates how many cells are replicating.

HIV-infected patients 18 years of age and older may be eligible for this study. Candidates will be screened with a medical history, physical examination, chest X-ray, electrocardiogram (EKG) and blood tests.

Read more

Participants will be given an infusion of BrDU through a catheter (thin plastic tube) placed in an arm vein. Blood will be drawn up to 4 times in the first 24 hours after the infusion.

Additional samples will then be collected as often as daily for the first week, twice a week for the next 3 weeks and then weekly to monthly for up to 1 year. Some patients may undergo a tissue biopsy (removal of a small tissue sample from a lymph node, tonsil or colon) or computed tomography (CT) scans of the thymus (a small gland between the lungs that manufactures lymphocytes. Some patients will have a second infusion in order to examine changes in the rate of CD4 replication over time or following potent antiretroviral therapy. Patients will be followed in the clinic periodically for the first year and then will be seen in the clinic or contacted by telephone once a year for 4 more years.

The results of this study may provide a better understanding of how HIV causes disease and how therapy affects the immune system.

Read the detailed description

Understanding the rate of lymphocyte replication and destruction in HIV infected patients, as well as the effects of therapy on lymphocyte replication should lead to a better understanding of the mechanisms behind the immunodeficiency induced by HIV. To examine this directly, up to 85 HIV-infected patients will be enrolled in the study. Patients will receive up to two 30 minute infusions (at least one month apart) of bromodeoxyuridine (BrDU; 200 mg/m(2)), an analogue of thymidine. BrDU is incorporated into DNA and can be measured using an anti-BrDU monoclonal antibody. It can be measured in subpopulations of cells to determine the rate of replication of those cells. All participants in this study will be reimbursed for the inconvenience and discomfort associated with study participation.

Keywords
BrDU, HIV, Labeling, CD4 Cells, Immunodeficiency
Medical subject headings
HIV Infections, Acquired Immunodeficiency Syndrome, Immunologic Deficiency Syndromes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 1999 (estimated)
  2. Study start19 Sep 1997
  3. Study completion13 May 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00001650
Sponsor's protocol ID
970189
Other IDs
97-I-0189
Status last verified
13 May 2011
First submitted
3 Nov 1999
Last updated
2 Jul 2017
Results posted
No

Publications

  • Ho DD, Neumann AU, Perelson AS, Chen W, Leonard JM, Markowitz M. Rapid turnover of plasma virions and CD4 lymphocytes in HIV-1 infection. Nature. 1995 Jan 12;373(6510):123-6. doi: 10.1038/373123a0.

    PubMed 7816094

  • Wolthers KC, Bea G, Wisman A, Otto SA, de Roda Husman AM, Schaft N, de Wolf F, Goudsmit J, Coutinho RA, van der Zee AG, Meyaard L, Miedema F. T cell telomere length in HIV-1 infection: no evidence for increased CD4+ T cell turnover. Science. 1996 Nov 29;274(5292):1543-7. doi: 10.1126/science.274.5292.1543.

    PubMed 8929418

  • Sprent J, Tough DF. Lymphocyte life-span and memory. Science. 1994 Sep 2;265(5177):1395-400. doi: 10.1126/science.8073282.

    PubMed 8073282

Questions about this trial

What is this clinical trial studying?

An observational study of HIV Infection and Acquired Immunodeficiency Syndrome, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00001650, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.

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