Status:
COMPLETED
Bone Mineral Density Substudy - An Ancillary Study to MTN-003
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Microbicide Trials Network
Conditions:
HIV Infections
Eligibility:
FEMALE
18-45 years
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) - ora...
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...
Eligibility Criteria
Inclusion
- Enrolled in MTN-003
- Randomized to oral study product in MTN-003 within 14 days prior to study entry
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
518 Patients enrolled
Trial Details
Trial ID
NCT00729573
Start Date
November 1 2009
End Date
May 1 2013
Last Update
February 8 2023
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
MU-JHU Research Collaboration (MUJHU CARE LTD) CRS
Kampala, Uganda
2
Seke South CRS
Chitungwiza, Zimbabwe
3
Zengeza CRS
Chitungwiza, Zimbabwe
4
Spilhaus CRS
Harare, Zimbabwe