Bone Mineral Density Substudy - An Ancillary Study to MTN-003
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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 |
- Changes in bone mineral density [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- 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:
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
|
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 |
Sexually active, HIV-uninfected women who are currently enrolled in MTN-003
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00729573
| 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 | |
| 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: | February 23, 2015 |
| 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:
|
Emtricitabine Tenofovir Tenofovir disoproxil Anti-HIV Agents Anti-Infective Agents Anti-Retroviral Agents Antiviral Agents |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Nucleic Acid Synthesis Inhibitors Pharmacologic Actions Reverse Transcriptase Inhibitors Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015