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

This study has been completed.
Sponsor:
Collaborator:
Microbicide Trials Network
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00729573
First received: August 6, 2008
Last updated: September 30, 2013
Last verified: September 2013

August 6, 2008
September 30, 2013
November 2009
May 2013   (final data collection date for primary outcome measure)
Changes in bone mineral density [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00729573 on ClinicalTrials.gov Archive Site
Changes in nutrition [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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).

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Urine and blood samples

Probability Sample

Sexually active, HIV-uninfected women who are currently enrolled in MTN-003

HIV Infections
  • Drug: Emtricitabine/tenofovir disoproxil fumarate
    200 mg/300 mg tabletas a part of MTN-003
    Other Names:
    • FTC/TDF
    • Truvada
  • Drug: Emtricitabine/tenofovir disoproxil fumarate placebo
    placebo tablet as a part of MTN-003
    Other Names:
    • FTC/TDF placebo
    • Truvada placebo
  • Drug: Tenofovir disoproxil fumarate
    300 mg tablet as a part of MTN-003
    Other Name: TDF
  • Drug: Tenofovir disoproxil fumarate placebo
    placebo tablet as a part of MTN-003
    Other Name: TDF placebo
1
Participants in MTN-003. Participants will remain a part of their assigned MTN-003 study groups.
Interventions:
  • Drug: Emtricitabine/tenofovir disoproxil fumarate
  • Drug: Emtricitabine/tenofovir disoproxil fumarate placebo
  • Drug: Tenofovir disoproxil fumarate
  • Drug: Tenofovir disoproxil fumarate placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
518
May 2013
May 2013   (final data collection date for primary outcome measure)

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
Female
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Uganda,   Zimbabwe
 
NCT00729573
MTN-003B, 10709
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Microbicide Trials Network
Study Chair: Sharon A. Riddler, MD, MPH University of Pittsburgh
National Institute of Allergy and Infectious Diseases (NIAID)
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP