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Completed

NCT Number: NCT00729573

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

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).

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

MU-JHU Research Collaboration (MUJHU CARE LTD) CRS, Kampala, Uganda

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Emtricitabine/Tenofovir disoproxil fumarate

Drug

200 mg/300 mg tabletas a part of MTN-003

Other names: FTC/TDF, Truvada

Emtricitabine/tenofovir disoproxil fumarate placebo

Drug

placebo tablet as a part of MTN-003

Other names: FTC/TDF placebo, Truvada placebo

Tenofovir disoproxil fumarate

Drug

300 mg tablet as a part of MTN-003

Other names: TDF

Tenofovir disoproxil fumarate placebo

Drug

placebo tablet as a part of MTN-003

Other names: TDF placebo

Primary outcomes

  1. Changes in bone mineral density

    Time frame: Throughout study

Secondary outcomes

  1. Changes in nutrition

    Time frame: Throughout study

Sponsors and collaborators

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Nih

Collaborators

  • Microbicide Trials Network

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Aug 7, 2008
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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