Trial record 13 of 48 for:    HIV AND "treatment naive" | Open Studies | HIV

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
Information provided by:
East Carolina University Identifier:
First received: April 26, 2011
Last updated: April 27, 2011
Last verified: April 2011

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by East Carolina University:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • 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

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
Genders Eligible for Study:   Both
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
No Contacts or Locations Provided
  More Information

No publications provided

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
Health Authority: United States: Institutional Review Board

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
HIV Protease Inhibitors
Anti-HIV Agents
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Vitamin D
Efavirenz, emtricitabine, tenofovir disoproxil fumarate drug combination
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Growth Substances
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents processed this record on April 22, 2014