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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

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
History of Changes
  Purpose

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.


Condition Intervention Phase
HIV
 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:

U.S. FDA Resources

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
comparator
 Drug: atripla
once a day
Experimental: darunavir ritonavir raltegravir
experimental
 Drug: darunavir ritonavir raltegravir
as directed

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
ClinicalTrials.gov 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
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
Ergocalciferols
Vitamins
Ritonavir
 Darunavir
Efavirenz, emtricitabine, tenofovir disoproxil fumarate drug combination
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on March 10, 2013