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

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: Female

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).

• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Microbicide Trials Network
• Treatments: Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Tenofovir

Criteria

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