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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00729573

Enrollment

518

Registered

2008-08-07

Start date

2009-11-30

Completion date

2013-05-31

Last updated

2023-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

Microbicide, HIV Seronegativity, Bone Mineral Density

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.

Interventions

DRUGEmtricitabine/tenofovir disoproxil fumarate

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

DRUGEmtricitabine/tenofovir disoproxil fumarate placebo

placebo tablet as a part of MTN-003

DRUGTenofovir disoproxil fumarate

300 mg tablet as a part of MTN-003

DRUGTenofovir disoproxil fumarate placebo

placebo tablet as a part of MTN-003

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Changes in bone mineral density	Throughout study

Secondary

Measure	Time frame
Changes in nutrition	Throughout study

Countries

Uganda, Zimbabwe

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026