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

Completed

• Conditions: HIV Infections
• Interventions: Drug: Emtricitabine/tenofovir disoproxil fumarate; Drug: Emtricitabine/tenofovir disoproxil fumarate placebo; Drug: Tenofovir disoproxil fumarate; Drug: Tenofovir disoproxil fumarate placebo

• Registration Number: NCT00729573
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief 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).

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 Timeline

• Study First Submitted: 2008-08-06
• Study First Submitted QC: 2008-08-06
• Study First Posted: 2008-08-07
• Study Start: 2009-11
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2021-10
• Last Update Submitted: 2023-02-06
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 518

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Emtricitabine/tenofovir disoproxil fumarate placebo	Participants in MTN-003. Participants will remain a part of their assigned MTN-003 study groups.
1	Tenofovir disoproxil fumarate placebo	Participants in MTN-003. Participants will remain a part of their assigned MTN-003 study groups.
1	Emtricitabine/tenofovir disoproxil fumarate	Participants in MTN-003. Participants will remain a part of their assigned MTN-003 study groups.
1	Tenofovir disoproxil fumarate	Participants in MTN-003. Participants will remain a part of their assigned MTN-003 study groups.

Primary Outcome Measures

Name	Time	Method
Changes in bone mineral density	Throughout study

Secondary Outcome Measures

Name	Time	Method
Changes in nutrition	Throughout study

Trial Locations

Locations (4)

Seke South CRS; 🇿🇼 Chitungwiza, Zimbabwe

MU-JHU Research Collaboration (MUJHU CARE LTD) CRS; 🇺🇬 Kampala, Uganda

Zengeza CRS; 🇿🇼 Chitungwiza, Zimbabwe

Spilhaus CRS; 🇿🇼 Harare, Zimbabwe