CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
Probiotic compounddietary
Likely dose
Not stated in 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/NCT02640625
NCT02640625Phase 2Completed
CompareCT.gov

Adjuvant Mucosal Therapy in HIV-infected Men With Insufficient Response to Antiretroviral Therapy

Oslo University Hospital·interventional·Posted Dec 29, 2015·Updated Dec 6, 2021

In Brief

A Phase 2 clinical trial evaluating Probiotic compound for Human Immunodeficiency Virus. Completed, enrolled 20 participants across 1 site.

Detailed Summary

The primary objective of this study is to assess the safety of probiotics in cART-treated immunologic non-responder (INR) patients with chronic HIV infection. The secondary objectives are to i) explore the biological effects of probiotics in combined antiretroviral therapy(cART)-treated INR patient with chronic HIV infection, and ii) investigate differences between cART-treated HIV-infected INR and non-INR patients with regards to gut microbial composition and mucosal barrier function.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHuman Immunodeficiency Virus
CountriesNorway
CollaboratorsUniversity of Oslo

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 29, 2015
Enrollment StartJan 1, 2016
Primary CompletionMar 1, 2017
Study CompletionApr 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 10.5 years ago

Interventions

Probiotic compounddietary

Lactobacillus rhamnosus GG, Lactobacillus acidophilus, Lactobacillus bulgaricus, Bifidobacterium animalis subsp. lactis, and Streptococcus thermophilus.