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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2011 by East Carolina University.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01343225
First Posted: April 28, 2011
Last Update Posted: April 28, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
East Carolina University
April 26, 2011
April 28, 2011
April 28, 2011
May 2011
May 2014   (Final data collection date for primary outcome measure)
Vitamin D levels and bone density [ Time Frame: 48 weeks ]
collection of vitamin d levels and bone density measured before and at end of 48 weeks
Same as current
No Changes Posted
viral load and CD 4 count [ Time Frame: 48 weeks ]
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
Intervention Model: Parallel Assignment
Masking: None (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.
 
Unknown status
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
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01343225
IISP # 38879
No
Not Provided
Not Provided
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