Clinical Trials


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.

Verified April 2011

East Carolina University

Information provided by (Responsible Party)
East Carolina University Identifier

First received: April 26, 2011
Last updated: April 27, 2011
Last Verified: April 2011
History of Changes


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).


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.

Condition Intervention Phase

Drug : atripla
Drug : darunavir ritonavir raltegravir
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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

Further study details as provided by East Carolina University:

Primary Outcome Measures

  • 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
Secondary Outcome Measures:
  • viral load and CD 4 count [ Time Frame: 48 weeks ]
    Viral load and CD 4 at baseline and 48 weeks

Estimated Enrollment: 40
Study Start Date: May 2011
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Active Comparator: atripla
Drug: atripla

once a day

Experimental: darunavir ritonavir raltegravir
Drug: darunavir ritonavir raltegravir

as directed



Ages Eligible for Study: 18 Years to 50 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  


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

contacts and locations

Contacts and Locations

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Please refer to this study by its identifier: NCT01343225

Sponsors and Collaborators

East Carolina University
More Information

More Information

Responsible Party: Paul Cook, East Carolina University Identifier: NCT01343225   History of Changes  
Other Study ID Numbers: IISP # 38879  
Study First Received: April 26, 2011  
Last Updated: April 27, 2011  

Keywords provided by East Carolina University:

African american vitamin d bone density
African American male or female treatment naive

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Vitamin D
Raltegravir Potassium
Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination processed this data on July 17, 2019
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