Clinical Trials

MainTitle

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

This study has been completed
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

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: March 8, 2016
Last Verified: March 2016
History of Changes
Purpose

Purpose

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).

Condition Intervention
HIV Infections

Drug : Emtricitabine/tenofovir disoproxil fumarate
Drug : Emtricitabine/tenofovir disoproxil fumarate placebo
Drug : Tenofovir disoproxil fumarate
Drug : Tenofovir disoproxil fumarate placebo

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures

  • Changes in bone mineral density [ Time Frame: Throughout study ]
Secondary Outcome Measures:
  • Changes in nutrition [ Time Frame: Throughout study ]

Biospecimen Retention: Samples With DNA
Urine and blood samples

Enrollment: 518
Study Start Date: November 2009
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1
Participants in MTN-003. Participants will remain a part of their assigned MTN-003 study groups.
Drug: Emtricitabine/tenofovir disoproxil fumarate

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

Other Name:
  • FTC/TDF
  • Truvada

Drug: Emtricitabine/tenofovir disoproxil fumarate placebo

placebo tablet as a part of MTN-003

Other Name:
  • 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

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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 45 Years  
Sexes Eligible for Study: Female  
Accepts Healthy Volunteers: Yes  
Sampling Method: Probability Sample  

Study Population

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

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00729573

Locations

Uganda
MU-JHU Research Collaboration (MUJHU CARE LTD) CRS
Kampala, Uganda
Zimbabwe
Seke South CRS
Chitungwiza, Zimbabwe
Zengeza CRS
Chitungwiza, Zimbabwe
Spilhaus CRS
Harare, Zimbabwe

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)
Microbicide Trials Network

Investigators

Study Chair: Sharon A. Riddler, MD, MPH University of Pittsburgh
More Information

More Information

Additional Information:

Click here for the Microbicide Trials Network Web site

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)  
ClinicalTrials.gov Identifier: NCT00729573   History of Changes  
Other Study ID Numbers: MTN-003B  
  10709  
Study First Received: August 6, 2008  
Last Updated: March 8, 2016  

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

Microbicide
HIV Seronegativity
Bone Mineral Density

Additional relevant MeSH terms:
Infection
HIV Infections
Acquired Immunodeficiency Syndrome
Tenofovir
Emtricitabine
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

ClinicalTrials.gov processed this data on March 27, 2020
This information is provided by ClinicalTrials.gov.