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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

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ClinicalTrials.gov 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
Sponsor:
Information provided by:

Study Description
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).

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

Study Design

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

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: atripla
comparator
Drug: atripla
once a day
Experimental: darunavir ritonavir raltegravir
experimental
Drug: darunavir ritonavir raltegravir
as directed


Outcome Measures

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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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
More Information

Responsible Party: Paul Cook, East Carolina University
ClinicalTrials.gov Identifier: NCT01343225     History of Changes
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:
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
Vitamins
Vitamin D
Ergocalciferols
Ritonavir
Darunavir
Raltegravir Potassium
Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents