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NCT00238459 · ClinicalTrials.gov registry record
Controlling Acute or Early HIV Infection With Antiretroviral Drugs, Without a Candidate Vaccine.As Reported Previously, the Candidate Vaccie Was Not Provided by the Maufacturer as Promised
A clinical trial, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- 58
- Enrollment target
NCT00238459 is a clinical trial that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 58 participants.
The verdict
NCT00238459 has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- 58 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the role of HIV-specific CD4 T cell responses and immune responses dependent upon these CD4 responses that develop when antiretroviral drugs are started during acute or recent HIV infection, whether these CD4 responses can be enhanced with a therapeutic HIV vaccine (HIV-1 immunogen), and what pattern of HIV-specific immune responses is associated with control of HIV upon discontinuation of antiretroviral drugs during an analytical therapeutic interruption. Participants will be treatment-naive adults with acute or early HIV infection who will choose to start or not start anti-HIV drugs at the beginning of the study. NOTE: In August 2007 we were notified by the manufacturer of the candidate vaccine that they were no longer making the vaccine, and that the vaccine would no longer be available. Unfortunately too few participants have received either the vaccine or placebo to conclude anything about efficacy. No safety problems occurred.
Interventions
- DRUG Patients elected to take licensed drugs. The vaccine was not provided for evaluation
- DRUG multiple licensed drugs not randomized
- DRUG multiple licensed antiretroviral drugs; not randomized
- OTHER Intended vaccine not provided, Licensed drugs provided, but were not investigated
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2005-07 |
| Est. Completion | 2013-10 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00238459
The ClinicalTrials.gov registry entry for NCT00238459 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 58 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Patients elected to take licensed drugs. The vaccine was not provided for evaluation is the first listed.
NCT00238459 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00238459 about?
NCT00238459 is a clinical study titled "Controlling Acute or Early HIV Infection With Antiretroviral Drugs, Without a Candidate Vaccine.As Reported Previously, the Candidate Vaccie Was Not Provided by the Maufacturer as Promised". The purpose of this study is to determine the role of HIV-specific CD4 T cell responses and immune responses dependent upon these CD4 responses that develop when antiretroviral drugs are started during acute or recent HIV infection, whether these CD4 responses can be enhanced with a therapeutic HIV ...
What is the current status of trial NCT00238459?
This trial is currently completed. The enrollment target is 58 participants. The study started on 2005-07. Estimated completion is 2013-10.
What interventions are being tested in trial NCT00238459?
The interventions under investigation include: Patients elected to take licensed drugs. The vaccine was not provided for evaluation (DRUG), multiple licensed drugs not randomized (DRUG), multiple licensed antiretroviral drugs; not randomized (DRUG), Intended vaccine not provided, Licensed drugs provided, but were not investigated (OTHER).
Who is sponsoring clinical trial NCT00238459?
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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