Working… Menu

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 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. Identifier: NCT01343225
Recruitment Status : Unknown
Verified April 2011 by East Carolina University.
Recruitment status was:  Not yet recruiting
First Posted : April 28, 2011
Last Update Posted : April 28, 2011
Information provided by:
East Carolina University

Brief Summary:

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 or disease Intervention/treatment Phase
HIV Drug: atripla Drug: darunavir ritonavir raltegravir Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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
Study Start Date : May 2011
Estimated Primary Completion Date : May 2014
Estimated Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: atripla
Drug: atripla
once a day

Experimental: darunavir ritonavir raltegravir
Drug: darunavir ritonavir raltegravir
as directed

Primary Outcome Measures :
  1. 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 :
  1. viral load and CD 4 count [ Time Frame: 48 weeks ]
    Viral load and CD 4 at baseline and 48 weeks

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
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
Layout table for additonal information
Responsible Party: Paul Cook, East Carolina University Identifier: NCT01343225    
Other Study ID Numbers: IISP # 38879
First Posted: April 28, 2011    Key Record Dates
Last Update Posted: April 28, 2011
Last Verified: April 2011
Keywords provided by East Carolina University:
African american vitamin d bone density
African American male or female treatment naive
Additional relevant MeSH terms:
Layout table for MeSH terms
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Raltegravir Potassium
Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
HIV Integrase Inhibitors
Integrase Inhibitors
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors