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NCT01543958 · ClinicalTrials.gov registry record · Phase 2
Sevelamer for Reducing Endotoxemia and Immune Activation
A Phase 2 study, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT01543958: Completed Phase 2 study, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.
NCT01543958 is a Phase 2 study that has completed, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections. The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01543958, a Phase 2 study, has completed, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
Study Summary
HIV-infected people can have an increase in inflammation in their body organs, even after taking anti-HIV medicines. Sevelamer carbonate is used to bind phosphate in dialysis patients. It can also bind endotoxin in the gut and lowers endotoxin levels in the blood of dialysis patients. Sevelamer carbonate decreases the inflammation endotoxin causes in dialysis patients. A5296 is a phase II, single-arm study to evaluate the effect of 8 weeks of sevelamer carbonate administration on markers of microbial translocation and T-cell activation in the blood in chronically HIV-infected subjects not receiving ART.
Primary Outcome
Change in LPS from baseline to week 8, where baseline value is the average of pre-entry and entry values.
Interventions
- DRUG Sevelamer carbonate
- DEVICE Sevelamer carbonate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2011-11 |
| Est. Completion | 2012-11 |
| Phase | Phase 2 |
What the finished NCT01543958 record still lists
NCT01543958 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 2 interventions - of which Sevelamer carbonate is the first listed.
NCT01543958 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01543958 about?
NCT01543958 is a clinical study titled "Sevelamer for Reducing Endotoxemia and Immune Activation". HIV-infected people can have an increase in inflammation in their body organs, even after taking anti-HIV medicines. Sevelamer carbonate is used to bind phosphate in dialysis patients. It can also bind endotoxin in the gut and lowers endotoxin levels in the blood of dialysis patients. Sevelamer car...
What is the current status of trial NCT01543958?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2011-11. Estimated completion is 2012-11.
What interventions are being tested in trial NCT01543958?
The interventions under investigation include: Sevelamer carbonate (DRUG), Sevelamer carbonate (DEVICE).
Who is sponsoring clinical trial NCT01543958?
This trial is sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, which has 45 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01543958's enrollment target sits among peer trials
40 1362nd of 2000 higher than 542 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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