NCT05022212

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: Female
• Age: 18 Years – 23 Years
• Healthy volunteers: Not accepted

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.

Detailed description

We will conduct a randomized, placebo-controlled trial of the vaginal live biotherapeutic product LACTIN-V in 60 young South African women. After being informed about the study and potential risks, all participants giving written informed consent will be enrolled if they meet eligibility criteria. At enrollment on Day 1, they will start a 7-day course of standard oral metronidazole treatment for bacterial vaginosis. Women who completed their metronidazole treatment will be randomized 2:1 to LACTIN-V vs. placebo. Within 8-48 hours of the final metronidazole dose, women will receive the study product for five consecutive days, followed by twice weekly for three additional weeks. Women will be followed during the dosing (4 weeks) and post-dosing phase (4 weeks) for a total of 64 days.

Conditions

• Bacterial Vaginosis
• HIV Infections

Interventions

Type	Name	Description
DRUG	LACTIN-V	administered vaginally
DRUG	Placebo	administered vaginally

Timeline

• Start date: 2021-05-10
• Primary completion: 2023-03-31
• Completion: 2023-03-31
• First posted: 2021-08-26
• Last updated: 2024-08-13
• Results posted: 2024-08-13

Locations

1 site across 1 country: South Africa

Regulatory

• FDA-regulated drug study