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

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ClinicalTrials.gov Identifier: NCT00729573
Recruitment Status : Completed
First Posted : August 7, 2008
Last Update Posted : March 9, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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) - 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 or disease Intervention/treatment
HIV Infections Drug: Emtricitabine/tenofovir disoproxil fumarate Drug: Emtricitabine/tenofovir disoproxil fumarate placebo Drug: Tenofovir disoproxil fumarate Drug: Tenofovir disoproxil fumarate 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.


Study Design

Study Type : Observational
Actual Enrollment : 518 participants
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
Study Start Date : November 2009
Primary Completion Date : May 2013
Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Changes in bone mineral density [ Time Frame: Throughout study ]

Secondary Outcome Measures :
  1. Changes in nutrition [ Time Frame: Throughout study ]

Biospecimen Retention:   Samples With DNA
Urine and blood samples

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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 ( Registry Identifier: DAIDS-ES Registry Number )
First Posted: August 7, 2008    Key Record Dates
Last Update Posted: March 9, 2016
Last Verified: March 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
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
Tenofovir
Emtricitabine
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents