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NCT01338025 · ClinicalTrials.gov registry record · Phase 4
Evaluation of 3TC or FTC Mono-therapy Compared to Continuing HAART as a Bridging Strategy
A Phase 4 study, sponsored by International Maternal Pediatric Adolescent AIDS Clinical Trials Group.
- Terminated
- Registry status
- Phase 4
- Development phase
- 33
- Enrollment target
NCT01338025 is a Phase 4 study that was terminated before completion, run by International Maternal Pediatric Adolescent AIDS Clinical Trials Group. The registered enrollment target is 33 participants.
The verdict
NCT01338025, a Phase 4 study, was terminated before completion, sponsored by International Maternal Pediatric Adolescent AIDS Clinical Trials Group.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 33 participants
- Enrollment target
Study Summary
The purpose of this study was to compare the use of lamivudine (3TC) or emtricitabine (FTC) alone vs. continuing a failing highly active antiretroviral therapy (HAART) regimen in HIV infected children, adolescents and young adults. The study was to see if there were changes in the HIV virus and if there were differences in immune function, viral load and medication side effects between the two groups over 28 weeks. Participants were assigned to either take 3TC or FTC alone or continue on his/her current failing HAART regimen. During the first 28 weeks of this study, if the participant was randomized to the continue HAART arm, he/she was not switched to a different or new, potentially suppressive HAART regimen, but continued on the current failing HAART regimen. However, if continuing HAART, the participant might be switched to a new regimen if their provider felt that it was clinically needed or the participant met certain study endpoints (e.g., drop in CD4, increase in viral load). At the end of 28 weeks, the participant had the choice of remaining on the assigned study group medication(s) or starting a new HAART regimen prescribed by his/her doctor. Then, they would be followed for another 24 weeks to compare the difference in immune function, viral load and medication side effects between the different groups.
Interventions
- DRUG HAART regimen
- DRUG 3TC or FTC monotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2011-03 |
| Est. Completion | 2013-05 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01338025
The ClinicalTrials.gov registry entry for NCT01338025 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is International Maternal Pediatric Adolescent AIDS Clinical Trials Group, which has 17 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which HAART regimen is the first listed.
NCT01338025 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01338025 about?
NCT01338025 is a clinical study titled "Evaluation of 3TC or FTC Mono-therapy Compared to Continuing HAART as a Bridging Strategy". The purpose of this study was to compare the use of lamivudine (3TC) or emtricitabine (FTC) alone vs. continuing a failing highly active antiretroviral therapy (HAART) regimen in HIV infected children, adolescents and young adults. The study was to see if there were changes in the HIV virus and if t...
What is the current status of trial NCT01338025?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 33 participants. The study started on 2011-03. Estimated completion is 2013-05.
What interventions are being tested in trial NCT01338025?
The interventions under investigation include: HAART regimen (DRUG), 3TC or FTC monotherapy (DRUG).
Who is sponsoring clinical trial NCT01338025?
This trial is sponsored by International Maternal Pediatric Adolescent AIDS Clinical Trials Group, which has 17 total clinical trials registered on ClinicalTrials.gov.
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