Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT00000818 · ClinicalTrials.gov registry record · Phase 1

Evaluation of the Changes in HIV-1 Burden in Peripheral Blood and Lymphoid Tissue Following Zidovudine ( AZT ) Treatment in HIV-1-Infected Patients With CD4+ Cells Between 100 and 500 Cells/mm3.

A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 1
Development phase
18
Enrollment target

NCT00000818: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

NCT00000818 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT00000818, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
18 participants
Enrollment target

Study Summary

PRIMARY: To determine the effect of 8 weeks of zidovudine (AZT) treatment on the HIV-1 burden in peripheral blood and lymphoid tissue in HIV-1-infected, AZT-naive patients with CD4+ T lymphocyte counts between 100 and 500 cells/mm3. SECONDARY: To determine the extent to which apoptosis (programmed cell death) occurs in these patients. In previous trials of AZT treatment in HIV-infected patients, an antiviral effect has been clearly demonstrated by quantitative measurement of virus in plasma and peripheral blood mononuclear cells. However, the lymphoid tissues appear to be a major reservoir for HIV-1 and a major site of virus replication in HIV-infected persons. Further data is needed to assess the effect of treatment on viral burden and HIV-1 replication in lymphoid tissue.

Interventions

  • DRUG Zidovudine

Trial Details

FieldValue
Enrollment Target 18 participants
Phase Phase 1

What the finished NCT00000818 record still lists

NCT00000818 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).

The record links to 0 conditions, and to 1 intervention - of which Zidovudine is the first listed.

NCT00000818 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00000818 about?

NCT00000818 is a clinical study titled "Evaluation of the Changes in HIV-1 Burden in Peripheral Blood and Lymphoid Tissue Following Zidovudine ( AZT ) Treatment in HIV-1-Infected Patients With CD4+ Cells Between 100 and 500 Cells/mm3.". PRIMARY: To determine the effect of 8 weeks of zidovudine (AZT) treatment on the HIV-1 burden in peripheral blood and lymphoid tissue in HIV-1-infected, AZT-naive patients with CD4+ T lymphocyte counts between 100 and 500 cells/mm3. SECONDARY: To determine the extent to which apoptosis (programmed ...

What is the current status of trial NCT00000818?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants.

What interventions are being tested in trial NCT00000818?

The interventions under investigation include: Zidovudine (DRUG).

Who is sponsoring clinical trial NCT00000818?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00000818's enrollment target sits among peer trials

18 1720th of 2000 higher than 216 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT01245179 · 18 participants · Phase 1

    Study of Panobinostat (LBH589) in Patients With Sickle Cell Disease

  • NCT01999361 · 18 participants · NA

    Prevention of de Novo Allosensitization in Islet Transplant Recipients Following Complete Graft Loss

  • NCT02359825 · 18 participants · Phase 1

    Nerve Repair Using Hydrophilic Polymers to Promote Immediate Fusion of Severed Axons and Swift Return of Function

  • NCT02870244 · 18 participants · Phase 1

    Adoptive T Cell Immunotherapy for Advanced Melanoma Using Engineered Lymphocytes

Source: ClinicalTrials.gov NCT00000818, the US trial registry maintained by the National Library of Medicine. NCT00000818 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.