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| ID | Type | Description | Link |
|---|---|---|---|
| 10709 | Registry Identifier | DAIDS-ES Registry Number |
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| Name | Class |
|---|---|
| Microbicide Trials Network | NETWORK |
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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Participants in MTN-003. Participants will remain a part of their assigned MTN-003 study groups. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emtricitabine/tenofovir disoproxil fumarate | Drug | 200 mg/300 mg tabletas a part of MTN-003 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in bone mineral density | Throughout study |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in nutrition | Throughout study |
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Inclusion Criteria:
Exclusion Criteria:
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Sexually active, HIV-uninfected women who are currently enrolled in MTN-003
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| Name | Affiliation | Role |
|---|---|---|
| Sharon A. Riddler, MD, MPH | University of Pittsburgh | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MU-JHU Research Collaboration (MUJHU CARE LTD) CRS | Kampala | Uganda | ||||
| Seke South CRS |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16470118 | Background | Mayer KH, Maslankowski LA, Gai F, El-Sadr WM, Justman J, Kwiecien A, Masse B, Eshleman SH, Hendrix C, Morrow K, Rooney JF, Soto-Torres L; HPTN 050 Protocol Team. Safety and tolerability of tenofovir vaginal gel in abstinent and sexually active HIV-infected and uninfected women. AIDS. 2006 Feb 28;20(4):543-51. doi: 10.1097/01.aids.0000210608.70762.c3. | |
| 18328009 |
| Label | URL |
|---|---|
| Click here for the Microbicide Trials Network Web site | View source |
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Urine and blood samples
| Emtricitabine/tenofovir disoproxil fumarate placebo | Drug | placebo tablet as a part of MTN-003 |
|
|
| Tenofovir disoproxil fumarate | Drug | 300 mg tablet as a part of MTN-003 |
|
|
| Tenofovir disoproxil fumarate placebo | Drug | placebo tablet as a part of MTN-003 |
|
|
| Chitungwiza |
| Zimbabwe |
| Zengeza CRS | Chitungwiza | Zimbabwe |
| Spilhaus CRS | Harare | Zimbabwe |
| Rosen RK, Morrow KM, Carballo-Dieguez A, Mantell JE, Hoffman S, Gai F, Maslankowski L, El-Sadr WM, Mayer KH. Acceptability of tenofovir gel as a vaginal microbicide among women in a phase I trial: a mixed-methods study. J Womens Health (Larchmt). 2008 Apr;17(3):383-92. doi: 10.1089/jwh.2006.0325. |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069480 | Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| D000068679 | Emtricitabine |
| D000068698 | Tenofovir |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
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