NCT00729573

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
518

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2009

Typical duration for all trials

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 7, 2008

Completed
1.2 years until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

February 8, 2023

Status Verified

October 1, 2021

Enrollment Period

3.5 years

First QC Date

August 6, 2008

Last Update Submit

February 6, 2023

Conditions

HIV Infections

Keywords

MicrobicideHIV SeronegativityBone Mineral Density

Outcome Measures

Primary Outcomes (1)

  • Changes in bone mineral density

    Throughout study

Secondary Outcomes (1)

  • Changes in nutrition

    Throughout study

Study Arms (1)

1

Participants in MTN-003. Participants will remain a part of their assigned MTN-003 study groups.

Drug: Emtricitabine/tenofovir disoproxil fumarateDrug: Emtricitabine/tenofovir disoproxil fumarate placeboDrug: Tenofovir disoproxil fumarateDrug: Tenofovir disoproxil fumarate placebo

Interventions

Emtricitabine/tenofovir disoproxil fumarateDRUG

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

Also known as: FTC/TDF, Truvada
1
Emtricitabine/tenofovir disoproxil fumarate placeboDRUG

placebo tablet as a part of MTN-003

Also known as: FTC/TDF placebo, Truvada placebo
1
Tenofovir disoproxil fumarateDRUG

300 mg tablet as a part of MTN-003

Also known as: TDF
1
Tenofovir disoproxil fumarate placeboDRUG

placebo tablet as a part of MTN-003

Also known as: TDF placebo
1

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

MU-JHU Research Collaboration (MUJHU CARE LTD) CRS

Kampala, Uganda

Location

Seke South CRS

Chitungwiza, Zimbabwe

Location

Zengeza CRS

Chitungwiza, Zimbabwe

Location

Spilhaus CRS

Harare, Zimbabwe

Location

Related Publications (2)

  • 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.

    PMID: 16470118BACKGROUND

  • 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.

    PMID: 18328009BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Urine and blood samples

MeSH Terms

Conditions

HIV Infections

Interventions

Emtricitabine, Tenofovir Disoproxil Fumarate Drug CombinationEmtricitabineTenofovir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

OrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDrug CombinationsPharmaceutical Preparations

Study Officials

  • Sharon A. Riddler, MD, MPH

    University of Pittsburgh

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2008

First Posted

August 7, 2008

Study Start

November 1, 2009

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

February 8, 2023

Record last verified: 2021-10

Locations

ZI(3)UG(1)