CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
Lubiprostonedrug
Likely dose
Lubiprostone 24 mcgfrom 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/NCT01839734
NCT01839734Phase 2Completed
CompareCT.gov

LAMBCHOP-Lubiprostone Activity Among the MicroBiota of the Colon in HIV in Opposing Permeability: Pilot Study of Lubiprostone as a Modulator of Gut Microbial Translocation in HIV With Incomplete CD4 T-cell Recovery on Antiretroviral Therapy

Ruth M. Rothstein CORE Center·interventional·Posted Apr 25, 2013·Updated Aug 30, 2023

In Brief

A Phase 2 clinical trial evaluating Lubiprostone for HIV. Completed, enrolled 20 participants across 1 site.

Detailed Summary

The use of lubiprostone will decrease the levels of immune activation in HIV-infected subjects with incomplete CD4+ T-cell recovery with antiretroviral therapy (ART). * Lubiprostone will decrease levels of translocated gut microbial products in HIV-infected subjects with incomplete CD4+ T-cell recovery with ART. * The decrease in levels of translocated gut microbial products will be associated with a decline in the levels of immune activation in HIV-infected subjects with incomplete CD4+ T-cell recovery with ART.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 25, 2013
Enrollment StartJun 1, 2013
Primary CompletionApr 1, 2014
Study CompletionFeb 1, 2016
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 13.2 years ago

Interventions

Lubiprostonedrug

Lubiprostone 24 mcg by mouth (PO) once-daily