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
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Condition or disease | Intervention/treatment |
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HIV Infections | Drug: Emtricitabine/tenofovir disoproxil fumarate Drug: Emtricitabine/tenofovir disoproxil fumarate placebo Drug: Tenofovir disoproxil fumarate Drug: Tenofovir disoproxil fumarate placebo |
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 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 |
Actual Primary Completion Date : | May 2013 |
Actual Study Completion Date : | May 2013 |
Group/Cohort | Intervention/treatment |
---|---|
1
Participants in MTN-003. Participants will remain a part of their assigned MTN-003 study groups.
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Drug: Emtricitabine/tenofovir disoproxil fumarate
200 mg/300 mg tabletas a part of MTN-003
Other Names:
Drug: Emtricitabine/tenofovir disoproxil fumarate placebo
placebo tablet as a part of MTN-003
Other Names:
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
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- Changes in bone mineral density [ Time Frame: Throughout study ]
- Changes in nutrition [ Time Frame: Throughout study ]
Biospecimen Retention: Samples With DNA

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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 |
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

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