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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Emtricitabine/tenofovir disoproxil fumarate
* Drug: Emtricitabine/tenofovir disoproxil fumarate placebo
* Drug: Tenofovir disoproxil fumarate
* Drug: Tenofovir disoproxil fumarate placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Participants in MTN-003. Participants will remain a part of their assigned MTN-003 study groups. | Drug: Emtricitabine/tenofovir disoproxil fumarate<br>* 200 mg/300 mg tabletas a part of MTN-003<br>* Other names: Truvada;Drug: Emtricitabine/tenofovir disoproxil fumarate placebo<br>* placebo tablet as a part of MTN-003<br>* Other names: Truvada placebo;Drug: Tenofovir disoproxil fumarate<br>* 300 mg tablet as a part of MTN-003<br>* Other names: TDF;Drug: Tenofovir disoproxil fumarate placebo<br>* placebo tablet as a part of MTN-003<br>* Other names: TDF placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in bone mineral density |  | Throughout study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in nutrition |  | Throughout study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Microbicide, HIV Seronegativity, Bone Mineral Density