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Metabolic Impact Assessment of Tenofovir Disoproxil Fumarate on Non-HIV-1 Infected Healthy Adult Male Volunteers

NCT00648817 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2008-04-01

No results posted yet for this study

Summary

Metabolic changes commonly occur in HIV therapy. The purpose of this study is to assess the impact on insulin sensitivity from the administration of tenofovir disoproxil fumarate 300 mg compared with placebo in non-HIV-1 infected healthy adult males. Additionally, endothelial function, adipocytokines and lipids will be monitored.

Conditions

  • HIV Infections

Interventions

DRUG

Tenofovir Disoproxil Fumarate

Tenofovir DF 300 mg QD (equivalent to 245 mg of tenofovir disoproxil)

DRUG

Tenofovir DF placebo

Tenofovir DF placebo tablet QD

Sponsors & Collaborators

Principal Investigators

  • Graeme Moyle, MD, MB, BS, DipGUM · Chelsea and Westminster Hospital, London, UK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2007-11-30
Completion
2007-12-31

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00648817 on ClinicalTrials.gov