Effect of a Non-tenofovir, Non-efavirenz-based HIV Regimen on Bone Density and Vitamin D Levels in African-American Patients With HIV Infection

This study is not yet open for participant recruitment.
Verified April 2011 by East Carolina University
Sponsor:
Information provided by:
East Carolina University
ClinicalTrials.gov Identifier:
NCT01343225
First received: April 26, 2011
Last updated: April 27, 2011
Last verified: April 2011

April 26, 2011
April 27, 2011
May 2011
May 2014   (final data collection date for primary outcome measure)
Vitamin D levels and bone density [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
collection of vitamin d levels and bone density measured before and at end of 48 weeks
Same as current
Complete list of historical versions of study NCT01343225 on ClinicalTrials.gov Archive Site
viral load and CD 4 count [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
Viral load and CD 4 at baseline and 48 weeks
Same as current
Not Provided
Not Provided
 
Effect of a Non-tenofovir, Non-efavirenz-based HIV Regimen on Bone Density and Vitamin D Levels in African-American Patients With HIV Infection
Pilot Study of the Effect of a Non-tenofovir, Non-efavirenz-based HIV Regimen on Bone Density and Vitamin D Levels in African-American Patients With HIV Infection

2. Objectives

  1. To determine the vitamin D status of African-American HIV patients who are HIV-treatment naïve.
  2. To compare the effects of an efavirenz-containing regimen to a protease inhibitor regimen on 25-hydroxyvitamin D and 1,25 dihydroxyvitamin D3 levels.
  3. To compare the effect on bone density of a tenofovir- and efavirenz-containing regimen to a regimen that does not contain these drugs.
  4. To compare the efficacy of an alternative regimen (raltegravir, darunavir, ritonavir) to a standard once-daily regimen (tenofovir-emtricitabine-efavirenz).

Hypothesis

The investigators hypothesize that patients receiving efavirenz will be more likely to have lower 25-hydroxyvitamin D and 1,25 dihydroxyvitamin D3levels based on the fact that efavirenz is an inducer of CYP3A4 and CYP24 enzymes that degrade 25-hydroxyvitamin D and 1,25 dihydroxyvitamin D3, respectively, to inactive metabolites. The investigators speculate that patients on a tenofovir-containing regimen will be more likely to have progression of bone density loss compared to those in the non-tenofovir-containing regimen.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
HIV
  • Drug: atripla
    once a day
  • Drug: darunavir ritonavir raltegravir
    as directed
  • Active Comparator: atripla
    comparator
    Intervention: Drug: atripla
  • Experimental: darunavir ritonavir raltegravir
    experimental
    Intervention: Drug: darunavir ritonavir raltegravir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
40
May 2014
May 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • age between 18 and 50 years old
  • HIV infection and HIV RNA > 4000 copies/ml of plasma

Exclusion Criteria:

  • known risks for osteoporosis, including low body mass index (BMI < 20)
  • chronic alcohol use
  • chronic steroid use
  • use of phenytoin or phenobarbital
  • chronic renal insufficiency (calculated glomerular filtration rate < 50 ml/min)
  • males with testosterone deficiency, and post-menopausal females will be excluded
Both
18 Years to 50 Years
No
Not Provided
Not Provided
 
NCT01343225
IISP # 38879
No
Paul Cook, East Carolina University
East Carolina University
Not Provided
Not Provided
East Carolina University
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP