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Phase 2 Trial of LACTIN-V in Women at High Risk of HIV Acquisition

NCT05022212 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2024-08-13

Study results available
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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.

Conditions

  • Bacterial Vaginosis
  • HIV Infections

Interventions

DRUG

LACTIN-V

administered vaginally

DRUG

Placebo

administered vaginally

Sponsors & Collaborators

  • University of KwaZulu

    collaborator OTHER

  • Harvard University

    collaborator OTHER

  • Aurum Institute

    collaborator OTHER

  • Health Systems Trust

    collaborator OTHER

  • Osel, Inc.

    collaborator INDUSTRY

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • University of California, San Francisco

    lead OTHER

Principal Investigators

  • Craig R Cohen, MD MPH · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
23 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-10
Primary Completion
2023-03-31
Completion
2023-03-31
FDA Drug
Yes

Countries

  • South Africa

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05022212 on ClinicalTrials.gov