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
  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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in nutrition [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

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)
Groups/Cohorts 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 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

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

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
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
Makerere University- JHU Research Collaboration {MUJHU CARE LTD} CRS
Kampala, Mpigi, Uganda
Zimbabwe
Seke South CRS
Chitungwiza, Zimbabwe
Zengeza CRS
Chitungwiza, Zimbabwe
Spilhaus CRS
Harare, Zimbabwe
Sponsors and Collaborators
Microbicide Trials Network
Investigators
Study Chair: Sharon A. Riddler, MD, MPH University of Pittsburgh
  More Information

Additional Information:
Publications:
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: September 30, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Microbicide
HIV Seronegativity
Bone Mineral Density

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Infection
Communicable Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Emtricitabine
Tenofovir
Tenofovir disoproxil
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents

ClinicalTrials.gov processed this record on September 29, 2014