Bone Mineral Density Substudy - An Ancillary Study to MTN-003 - Full Text View

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

Resource links provided by NLM:

MedlinePlus related topics: Bone Density HIV/AIDS Minerals

Drug Information available for: Formic acid Emtricitabine Tenofovir Tenofovir Disoproxil Fumarate

U.S. FDA Resources

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:

Changes in bone mineral density [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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: FTC/TDF Truvada Drug: Emtricitabine/tenofovir disoproxil fumarate placebo placebo tablet as a part of MTN-003 Other Names: FTC/TDF placebo Truvada placebo 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

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:

FTC/TDF
Truvada

Drug: Emtricitabine/tenofovir disoproxil fumarate placebo

placebo tablet as a part of MTN-003

Other Names:

FTC/TDF placebo
Truvada placebo

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 (Adult)
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

Sexually active, HIV-uninfected women who are currently enrolled in MTN-003

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00729573

Locations


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

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Microbicide Trials Network

Investigators


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

More Information

Additional Information:

Click here for the Microbicide Trials Network Web site This link exits the ClinicalTrials.gov site

Publications:

Mayer KH, Maslankowski LA, Gai F, El-Sadr WM, Justman J, Kwiecien A, Mâsse 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.

Rosen RK, Morrow KM, Carballo-Diéguez 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.


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:	March 8, 2016
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:


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, Tenofovir Disoproxil Fumarate Drug Combination Emtricitabine 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

ClinicalTrials.gov processed this record on September 26, 2016