Intravaginal Treatment of Disturbances of Vaginal Flora Among HIV Infected and Uninfected Women in Malawi

NCT ID: NCT00140764

Last Updated: 2011-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-01-31
• Study Completion Date: 2005-03-31

Brief Summary

The purpose of this intervention is to find out whether intravaginal treatment with a gel containing an antibiotic (metronidazole), compared to a similar placebo gel (without antibiotic), can reduce the frequency of bacterial vaginosis, a common vaginal infection among African women who are HIV uninfected or HIV infected. The study will also determine the effect of these vaginal gels on genitourinary symptoms.

Detailed Description

This is a phase 3, randomized, double masked, two arms study conducted in Malawi, Southeast Africa. The study is conducted among nonpregnant HIV infected or uninfected women of reproductive age. Intermittent mass treatment approaches are followed where women are randomized to antibiotic intravaginal treatment or placebo at enrollment. Women receive assigned product every three months for one year.

Conditions

Bacterial Vaginosis; Trichomonas Vaginitis; Urogenital Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Metronidazole gel versus placebo gel

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Nonpregnant HIV-Uninfected HIV-Infected

Exclusion Criteria

Pregnant

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role: lead

Principal Investigators

Taha E Taha, MD PHD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Bloomberg School of Public Health

References

Aizire J, Dadabhai S, Taulo F, Makanani B, Gadama L, Sun J, Tsui A, Taha TE. Use of effective family planning methods and frequency of sex among HIV-infected and HIV-uninfected African women. Contracept Reprod Med. 2018 Jul 9;3:10. doi: 10.1186/s40834-018-0063-z. eCollection 2018.

Reference Type: DERIVED

PMID: 30002871 (View on PubMed)

Other Identifiers

METRO STUDY

Identifier Type: -

Identifier Source: org_study_id