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NCT00001644 · ClinicalTrials.gov registry record · Phase 1
Use of Combined Antiretroviral Therapy to Determine Sites of Persistent HIV Infection
A Phase 1 study of HIV Infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
- 1
- Study location
NCT00001644: Completed Phase 1 study of HIV Infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00001644 is a Phase 1 study of HIV Infection that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 42 participants, below the 242-participant average among 73 other HIV Infection trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001644, a Phase 1 study of HIV Infection, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will try to define how and where HIV infection persists in the body by determining: 1) if there are cells where HIV can live for long periods of time without being seen and destroyed by the immune system; 2) if there are sites where anti-HIV drugs cannot penetrate enough to stop new HIV replication; and 3) if HIV in certain lymph nodes can remain infectious for prolonged periods of time. It will also explore whether immune system damage caused by HIV can be repaired after new virus replication is stopped with treatment. HIV-infected patients 18 years of age and older may be eligible for this study, which will include three groups as follows. Candidates will be screened with a medical history, physical examination, blood and urine tests and possibly chest X-ray and electrocardiogram. Participants will be divided into three groups according to CD4 count levels: \> 500 cells/microliter of blood; between 300 and 500 cells/microliter, and \< 300 cells/microliter of blood. All participants will be treated with a combination of four antiretroviral drugs: indinavir, zidovudine, lamivudine and nevirapine. (Exceptions to this regimen may be made in certain circumstances for patients who cannot tolerate one of the four drugs.) In addition, they will undergo the following procedures: Blood tests - Blood tests will be done at screening and at study entry to evaluate the patient's health status and measure CD4 T cell count and plasma HIV levels; at the beginning of treatment to look for drug-related side effects; and during the course of the study to evaluate drug effectiveness in inhibiting HIV replication; CD4 T cell levels and function. Lymph node biopsy - Lymph node biopsies are done under local anesthesia. A small incision is made, the node is removed, and the incision is closed with stitches. Up to two nodes may be removed during each procedure. Patients with CD4 counts greater than 500 cells/microliter of blood and those with counts less than 300 cells/micro
Conditions Studied
Interventions
- DRUG Zidovudine
- DRUG Lamivudine
- DRUG Nevirapine
- PROCEDURE Blood testing
- DRUG Indinavir
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 1997-03-03 |
| Est. Completion | 2010-02-17 |
| Phase | Phase 1 |
What the finished NCT00001644 record still lists
NCT00001644 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 242-participant average among 73 other HIV Infection trials with a reported enrollment target (83% lower).
The record links to 1 condition, with HIV Infection appearing as the primary indexed condition, and to 5 interventions - of which Zidovudine is the first listed.
NCT00001644 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00001644 about?
NCT00001644 is a clinical study titled "Use of Combined Antiretroviral Therapy to Determine Sites of Persistent HIV Infection". This study will try to define how and where HIV infection persists in the body by determining: 1) if there are cells where HIV can live for long periods of time without being seen and destroyed by the immune system; 2) if there are sites where anti-HIV drugs cannot penetrate enough to stop new HIV r...
What is the current status of trial NCT00001644?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 1997-03-03. Estimated completion is 2010-02-17.
What conditions does trial NCT00001644 study?
This clinical trial studies the following conditions: HIV Infection.
What interventions are being tested in trial NCT00001644?
The interventions under investigation include: Zidovudine (DRUG), Lamivudine (DRUG), Nevirapine (DRUG), Blood testing (PROCEDURE), Indinavir (DRUG).
Who is sponsoring clinical trial NCT00001644?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00001644 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HIV Infection
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00001644's enrollment target sits among peer trials
42 43rd of 73 higher than 31 of 73 other HIV Infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infection 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.
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