Clinical trial NCT00729573: Bone Mineral Density Substudy - An Ancillary Study to MTN-003
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: Microbicide
HIV Seronegativity
Bone Mineral Density
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
Collaborators: name: Microbicide Trials Network
First posted: 2008-08-07
Enrollment: 518
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Sexually active, HIV-uninfected women who are currently enrolled in MTN-003

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).

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 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

Primary outcomes:
measure: Changes in bone mineral density
timeFrame: Throughout study
Secondary outcomes:
measure: Changes in nutrition
timeFrame: Throughout study
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: MU-JHU Research Collaboration (MUJHU CARE LTD) CRS
city: Chitungwiza
country: Zimbabwe
facility: Seke South CRS
city: Chitungwiza
country: Zimbabwe
facility: Zengeza CRS
city: Harare
country: Zimbabwe
facility: Spilhaus CRS
Study officials:
affiliation: University of Pittsburgh
name: Sharon A. Riddler, MD, MPH
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.