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NCT00043641 · ClinicalTrials.gov registry record
HIV Expression in Patients With Low Viral Load on Highly Active Antiretroviral Therapy (HAART)
A clinical trial, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- 73
- Enrollment target
NCT00043641: Completed study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00043641 is a clinical trial that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 73 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00043641 has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- 73 participants
- Enrollment target
Study Summary
This study will investigate low-level viral loads in HIV-infected patients taking highly active antiretroviral therapy (HAART). Although HAART reduces viral levels and restores immune function to some degree, it does not cure HIV infection. The virus persists even at levels below that which it can be detected. This study will examine where this residual virus comes from in order to better understand the infection and the effectiveness of therapies. In addition, the study will 1) evaluate the ability of a new test to detect the virus at low levels; and 2) determine whether adding the protease inhibitor Kaletra to the HAART treatment regimen for patients with a low viral load will further decrease their viral load. HIV-infected patients 18 years of age and older may be eligible for this study. Patients involved in the viral load test will be recruited from an NIAID HIV study in which they are already participating. Three groups of patients will be enrolled: those with a viral load of less than 50 copies/ml plasma, those with 51-500 copies/ml, and those with 501-5000 copies/ml. Patients involved in the Kaletra trial must have been taking HAART for 6 months or more and have less than 50 viral copies/ml plasma. They will be screened for this study with a history, physical examination, and routine laboratory tests. Participants in the viral load test evaluation will donate 70 ml of blood up to four times. No more than one sample will be collected per day. Participants in the Kaletra trial will have blood samples drawn on two successive days and will then be randomly assigned to one of two treatment groups. One group will begin Kaletra therapy (four capsules two times a day) immediately; the other will undergo observation for 4 weeks before starting Kaletra. Depending on what group they are in, patients will provide blood samples for viral load measurements and clinical samples according to the following schedule: Immediate Kaletra One sample each during weeks 1, 2, a
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 73 participants |
| Start Date | 2002-07-26 |
| Est. Completion | 2013-02-07 |
What the finished NCT00043641 record still lists
NCT00043641 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 73 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT00043641 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00043641 about?
NCT00043641 is a clinical study titled "HIV Expression in Patients With Low Viral Load on Highly Active Antiretroviral Therapy (HAART)". This study will investigate low-level viral loads in HIV-infected patients taking highly active antiretroviral therapy (HAART). Although HAART reduces viral levels and restores immune function to some degree, it does not cure HIV infection. The virus persists even at levels below that which it can b...
What is the current status of trial NCT00043641?
This trial is currently completed. The enrollment target is 73 participants. The study started on 2002-07-26. Estimated completion is 2013-02-07.
Who is sponsoring clinical trial NCT00043641?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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