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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

518 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-11-30

Study Completion Date

2013-05-31

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).

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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.

Conditions

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HIV Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Participants in MTN-003. Participants will remain a part of their assigned MTN-003 study groups.

Emtricitabine/tenofovir disoproxil fumarate

Intervention Type DRUG

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

Emtricitabine/tenofovir disoproxil fumarate placebo

Intervention Type DRUG

placebo tablet as a part of MTN-003

Tenofovir disoproxil fumarate

Intervention Type DRUG

300 mg tablet as a part of MTN-003

Tenofovir disoproxil fumarate placebo

Intervention Type DRUG

placebo tablet as a part of MTN-003

Interventions

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Emtricitabine/tenofovir disoproxil fumarate

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

Intervention Type DRUG

Emtricitabine/tenofovir disoproxil fumarate placebo

placebo tablet as a part of MTN-003

Intervention Type DRUG

Tenofovir disoproxil fumarate

300 mg tablet as a part of MTN-003

Intervention Type DRUG

Tenofovir disoproxil fumarate placebo

placebo tablet as a part of MTN-003

Intervention Type DRUG

Other Intervention Names

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FTC/TDF Truvada FTC/TDF placebo Truvada placebo TDF TDF placebo

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes