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NCT01245101 · ClinicalTrials.gov registry record · Phase 4
Addition of Raltegravir to Established Antiretroviral Suppressive Therapy
A Phase 4 study, sponsored by University of Miami.
- Terminated
- Registry status
- Phase 4
- Development phase
- 15
- Enrollment target
NCT01245101: Clinical Trial Phase 4 study, sponsored by University of Miami.
NCT01245101 is a Phase 4 study that was terminated before completion, run by University of Miami. The registered enrollment target is 15 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01245101, a Phase 4 study, was terminated before completion, sponsored by University of Miami.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 15 participants
- Enrollment target
Study Summary
This study will examine whether intensification with raltegravir of a suppressive antiretroviral regimen in HIV infected patients with poor immune restoration has a beneficial effect on cryptic viral replication and the immune system. Specifically, the investigators will examine the effect that raltegravir intensification of ART has on episomal cDNA frequencies, immune activation, CD4+ cell counts and apoptosis, and markers of microbial translocation.
Primary Outcome
These are linear viral cDNAs that are subsequently circularized by the DNA repair apparatus of the host cell to form episomes. They are markers of ongoing viral replication.
Interventions
- DRUG Raltegravir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2010-11 |
| Est. Completion | 2013-05 |
| Phase | Phase 4 |
Why NCT01245101 stopped before completion
NCT01245101 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Raltegravir is the first listed.
NCT01245101 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01245101 about?
NCT01245101 is a clinical study titled "Addition of Raltegravir to Established Antiretroviral Suppressive Therapy". This study will examine whether intensification with raltegravir of a suppressive antiretroviral regimen in HIV infected patients with poor immune restoration has a beneficial effect on cryptic viral replication and the immune system. Specifically, the investigators will examine the effect that ralt...
What is the current status of trial NCT01245101?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 15 participants. The study started on 2010-11. Estimated completion is 2013-05.
What interventions are being tested in trial NCT01245101?
The interventions under investigation include: Raltegravir (DRUG).
Who is sponsoring clinical trial NCT01245101?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01245101's enrollment target sits among peer trials
15 1880th of 2000 higher than 100 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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
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