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

February 6, 2023 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

Phase 2B Safety and Effectiveness Study of Tenofovir 1% Gel, Tenofovir Disproxil Fumarate Tablet and Emtricitabine/Tenofovir Disoproxil Fumarate Tablet for the Prevention of HIV Infection in Women

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The effect of tenofovir on bone mineral density (BMD) has not yet been studied and is of potential concern. The purpose of this study is to determine the changes in BMD among individuals receiving TDF and FTC/TDF compared with a placebo.

This substudy will enroll individuals currently participating in MTN-003. The expected duration of participation for each participant is approximately 48 months. Study treatment will be provided by MTN-003. Study treatment will not be provided by this substudy.

Study visits will occur every 6 months after enrollment. A nutrition assessment, physical activity history, and urine and blood collection will occur at all visits.

Study Type

Observational

Enrollment (Actual)

518

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Uganda
      • Kampala, Uganda
        • MU-JHU Research Collaboration (MUJHU CARE LTD) CRS
  • Zimbabwe
      • Chitungwiza, Zimbabwe
        • Seke South CRS
      • Chitungwiza, Zimbabwe
        • Zengeza CRS
      • Harare, Zimbabwe
        • Spilhaus CRS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Sexually active, HIV-uninfected women who are currently enrolled in MTN-003

Description

Inclusion Criteria:

  • Enrolled in MTN-003
  • Randomized to oral study product in MTN-003 within 14 days prior to study entry

Exclusion Criteria:

  • Medical condition known to affect bone or taking any medication known to affect bone. More information on this criterion can be found in the protocol.
  • Permanently discontinued from oral study product in MTN-003 prior to study entry
  • Any condition that, in the opinion of the investigator, would interfere with the study
  • Pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
Participants in MTN-003. Participants will remain a part of their assigned MTN-003 study groups.
Drug: Emtricitabine/tenofovir disoproxil fumarate
200 mg/300 mg tabletas a part of MTN-003
Other Names:
  • Truvada
  • FTC/TDF
Drug: Emtricitabine/tenofovir disoproxil fumarate placebo
placebo tablet as a part of MTN-003
Other Names:
  • FTC/TDF placebo
  • Truvada placebo
Drug: Tenofovir disoproxil fumarate
300 mg tablet as a part of MTN-003
Other Names:
  • TDF
Drug: Tenofovir disoproxil fumarate placebo
placebo tablet as a part of MTN-003
Other Names:
  • TDF placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in bone mineral density
Time Frame: Throughout study
Throughout study

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in nutrition
Time Frame: Throughout study
Throughout study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

Microbicide Trials Network

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (ACTUAL)

May 1, 2013

Study Completion (ACTUAL)

May 1, 2013

Study Registration Dates

First Submitted

August 6, 2008

First Submitted That Met QC Criteria

August 6, 2008

First Posted (ESTIMATE)

August 7, 2008

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 6, 2023

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MTN-003B
  • 10709 (REGISTRY: DAIDS-ES Registry Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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