CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 45 enrolled
Drug / intervention
LACTIN-V +1 moredrug
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/NCT05022212
NCT05022212Phase 2Completed
CompareCT.gov

Phase 2 Placebo-controlled Randomized Trial of LACTIN-V (Lactobacillus Crispatus CTV-05) Among Women at High Risk of HIV Acquisition in Durban, South Africa

University of California, San Francisco·interventional·Posted Aug 26, 2021·Updated Aug 13, 2024

In Brief

A Phase 2 clinical trial evaluating LACTIN-V and Placebo for Bacterial Vaginosis and HIV Infections. Completed, enrolled 45 participants across 1 site.

Detailed Summary

The purpose of this study is to assess the impact of LACTIN-V, a vaginally administered live biotherapeutic product (LBP) that contains the human L. crispatus CTV-05 strain, on the vaginal microbiome of Lactobacillus-deficient young women in the South African FRESH study who are at high risk for HIV acquisition.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBacterial Vaginosis, HIV Infections
CountriesSouth Africa
CollaboratorsUniversity of KwaZulu, Harvard University, Aurum Institute, Health Systems Trust, Osel, Inc., Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedAug 26, 2021
Enrollment StartMay 10, 2021
Primary CompletionMar 31, 2023
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 4.9 years ago

Interventions

LACTIN-Vdrug

administered vaginally

Placebodrug

administered vaginally