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

Sponsor:	National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator:	Microbicide Trials Network
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00729573

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:	Cohort, 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: AIDS Minerals

Drug Information available for: Tenofovir Tenofovir disoproxil Tenofovir Disoproxil Fumarate Truvada

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

Biospecimen Description:

Urine and blood samples

Estimated Enrollment:	300
Study Start Date:	November 2009

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 Drug: Emtricitabine/tenofovir disoproxil fumarate placebo placebo tablet as a part of MTN-003 Drug: Tenofovir disoproxil fumarate 300 mg tablet as a part of MTN-003 Drug: Tenofovir disoproxil fumarate placebo placebo tablet as a part of MTN-003

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 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.

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
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

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

Locations

Uganda
Makerere University- JHU Research Collaboration
Kampala, Uganda
Zimbabwe
Seke South CRS
Chitungwiza, Zimbabwe
Spilhaus CRS
Harare, Zimbabwe
Zengeza CRS
Chitungwiza, 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 more information about Emtricitabine/tenofovir disoproxil fumarate This link exits the ClinicalTrials.gov site

Click here for more information on tenofovir This link exits the ClinicalTrials.gov site

Click here for more information about tenofovir disoproxil fumarate This link exits the ClinicalTrials.gov site

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, 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.

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.

Responsible Party:	DAIDS ( Rona Siskind )
Study ID Numbers:	MTN-003B
Study First Received:	August 6, 2008
Last Updated:	November 24, 2009
ClinicalTrials.gov Identifier:	NCT00729573 History of Changes
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:

Communicable Diseases
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Infection
Reverse Transcriptase Inhibitors
Emtricitabine
Anti-Retroviral Agents
Therapeutic Uses
Tenofovir
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors

Tenofovir disoproxil
RNA Virus Infections
Anti-HIV Agents
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on February 08, 2010