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Bone Mineral Density Substudy - An Ancillary Study to MTN-003

NCT00729573 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 518

Last updated 2023-02-08

No results posted yet for this study

Summary

The MTN-003 HIV prevention study include the use of microbicides, substances that kill microbes, and tenofovir disoproxil fumarate (TDF) and emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) - oral, FDA-approved, anti-HIV drugs. The purpose of this study is to determine if taking daily TDF and FTC/TDF as a part of the study MTN-003 has an effect on bone mineral density (BMD).

Conditions

  • HIV Infections

Interventions

DRUG

Emtricitabine/tenofovir disoproxil fumarate

200 mg/300 mg tabletas a part of MTN-003

DRUG

Emtricitabine/tenofovir disoproxil fumarate placebo

placebo tablet as a part of MTN-003

DRUG

Tenofovir disoproxil fumarate

300 mg tablet as a part of MTN-003

DRUG

Tenofovir disoproxil fumarate placebo

placebo tablet as a part of MTN-003

Sponsors & Collaborators

  • Microbicide Trials Network

    collaborator NETWORK

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Sharon A. Riddler, MD, MPH · University of Pittsburgh

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2013-05-31
Completion
2013-05-31

Countries

  • Uganda
  • Zimbabwe

Study Locations

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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 NCT00729573 on ClinicalTrials.gov