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Ensayos clínicos

Ensayos clínicos

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

Patrocinador(es) del estudio: National Institute of Allergy and Infectious Diseases (NIAID)
Números de identificación: NCT00729573, MTN-003B
  • En curso, con inscripciones cerradas

Propósito del estudio

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).

Afección:
Infecciones por el VIH

Detalles del estudio

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 33 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.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 33 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.

Criterios de inclusión

    :
    • Enrolled in MTN-003
    • Randomized to oral study product in MTN-003 within 14 days prior to study entry

Criterios de exclusión

    :
    • 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

Centros de estudio/contactos

Mpigi

    Makerere University- JHU Research Collaboration {MUJHU CARE LTD} CRS, Kampala, Mpigi, Uganda

    Seke South CRS, Chitungwiza, Mpigi, Zimbabwe

    Zengeza CRS, Chitungwiza, Mpigi, Zimbabwe

    Spilhaus CRS, Harare, Mpigi, Zimbabwe

Actualizado: 26 de mayo del 2010

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