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NCT00729573 Clinical Trial

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

HIV Infections Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00729573
Other study ID # MTN-003B
Secondary ID 10709
Status Completed
Phase
First received
Last updated
Start date November 2009
Est. completion date May 2013

Study information
Verified date October 2021
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Completed
Enrollment 518
Est. completion date May 2013
Est. primary completion date May 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Emtricitabine/tenofovir disoproxil fumarate
200 mg/300 mg tabletas a part of MTN-003
• Emtricitabine/tenofovir disoproxil fumarate placebo
placebo tablet as a part of MTN-003
• Tenofovir disoproxil fumarate
300 mg tablet as a part of MTN-003
• Tenofovir disoproxil fumarate placebo
placebo tablet as a part of MTN-003

Locations
Country Name City State
Uganda MU-JHU Research Collaboration (MUJHU CARE LTD) CRS Kampala
Zimbabwe Seke South CRS Chitungwiza
Zimbabwe Zengeza CRS Chitungwiza
Zimbabwe Spilhaus CRS Harare

Sponsors (2)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) Microbicide Trials Network

Countries where clinical trial is conducted

Uganda,  Zimbabwe, 

References & Publications (2)

Mayer KH, Maslankowski LA, Gai F, El-Sadr WM, Justman J, Kwiecien A, Masse B, Eshleman SH, Hendrix C, Morrow K, Rooney JF, Soto-Torres L; HPTN 050 Protocol Team. Safety and tolerability of tenofovir vaginal gel in abstinent and sexually active HIV-infected and uninfected women. AIDS. 2006 Feb 28;20(4):543-51. doi: 10.1097/01.aids.0000210608.70762.c3. — View Citation

Rosen RK, Morrow KM, Carballo-Dieguez A, Mantell JE, Hoffman S, Gai F, Maslankowski L, El-Sadr WM, Mayer KH. Acceptability of tenofovir gel as a vaginal microbicide among women in a phase I trial: a mixed-methods study. J Womens Health (Larchmt). 2008 Apr;17(3):383-92. doi: 10.1089/jwh.2006.0325. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Changes in bone mineral density Throughout study
Secondary Changes in nutrition Throughout study
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