CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
Sevelamer carbonate +1 moredrug
Likely dose
Sevelamer carbonate 800 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01543958
NCT01543958Phase 2Completed
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Sevelamer Carbonate for Reducing Endotoxemia and Immune Activation: A Proof of Concept Study

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections·interventional·Posted Mar 5, 2012·Updated Oct 11, 2018

In Brief

A Phase 2 clinical trial evaluating Sevelamer carbonate for HIV-1 Infection. Completed, enrolled 40 participants across 15 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV-1 Infection
CountriesUnited States
CollaboratorsNational Institute of Allergy and Infectious Diseases (NIAID)

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 5, 2012
Enrollment StartNov 1, 2011
Primary CompletionSep 1, 2012
Study CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 14.3 years ago

Interventions

Sevelamer carbonatedrug

Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.

Sevelamer carbonatedevice