NCT02527941

Brief Summary

A non-randomized, interventional, longitudinal clinical study to quantify the impact of bacterial vaginosis treatment on HIV susceptibility and genital immunology in Kenyan women.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2015

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

August 14, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 19, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

February 10, 2016

Status Verified

February 1, 2016

Enrollment Period

3 months

First QC Date

August 14, 2015

Last Update Submit

February 9, 2016

Conditions

Bacterial VaginosisHIV Infections

Keywords

Genital immunologyHIV susceptibilityMicrobiomeBacterial vaginosisVirus entry assay

Outcome Measures

Primary Outcomes (2)

  • Percent HIV pseudovirus entry into cervical CD4+ T cells.

    The percentage of cervical CD4+ T cells per cytobrush infected ex vivo by an HIV pseudovirus construct will be quantified by flow cytometry.

    up to 8 months

  • Total number of cervical CD4+ T cells infected ex vivo with HIV.

    The total number of cervical CD4+ T cells per cytobrush infected ex vivo by an HIV pseudovirus construct will be quantified by flow cytometry.

    up to 8 months

Secondary Outcomes (4)

  • A genital inflammation score based on genital levels of pro-inflammatory cytokines and chemokines.

    up to 8 months

  • The cervico-vaginal microbiome.

    up to 8 months

  • Genital proteome analysis.

    up to 8 months

  • CD4+ expression of pre-defined HIV susceptibility markers

    up to 8 months

Study Arms (1)

metronidazole

EXPERIMENTAL

50 women who test negative for HIV and classical sexually transmitted infections but test positive for Bacterial Vaginosis will be treated with metronidazole at a dosage of 400mg/dose, 3 doses per day, for 7 days (as per Kenyan National Guidelines).

Drug: Metronidazole

Interventions

MetronidazoleDRUG

Participants will be provided with oral metronidazole 400mg po tid for one week, and followed up one month after treatment initiation.

Also known as: flagyl
metronidazole

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Participants are over 18 years of age, not pregnant and willing to give informed consent, and answer short questionnaires on economic status, and sexual risk behavior.
  • Willing to comply with the requirements of the protocol
  • HIV and classical STI (see below) negative
  • test positive for BV, defined as Nugent score from 7-10
  • willing to take oral metronidazole twice a day for 7 days
  • willing to abstain from alcohol during and for 48 hours after metronidazole treatment

You may not qualify if:

  • HIV infected
  • Deemed by physician to be unlikely to complete study protocol.
  • Pregnant.
  • Irregular menstrual cycle, or actively menstruating at the time of genital sampling.
  • Tested positive for classical STIs or having genital ulcers
  • Prior hysterectomy
  • Contraindication, allergy or intolerance to use of metronidazole

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kenya AIDS Vaccine Initiative Clinic

Nairobi, Kenya

Location

MeSH Terms

Conditions

Vaginosis, BacterialHIV Infections

Interventions

Metronidazole

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsVaginitisVaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

NitroimidazolesNitro CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Rupert Kaul, MD/PhD

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 14, 2015

First Posted

August 19, 2015

Study Start

August 1, 2015

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

February 10, 2016

Record last verified: 2016-02

Locations

KE(1)