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Clinical Trials

MainTitle

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

Sponsor
East Carolina University


Information provided by (Responsible Party)
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

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
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
comparator
Drug: atripla

once a day

Experimental: darunavir ritonavir raltegravir
experimental
Drug: darunavir ritonavir raltegravir

as directed

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 50 Years  
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

contacts and locations

Contacts and Locations

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01343225

Sponsors and Collaborators

East Carolina University
More Information

More Information


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  

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
Vitamins
Vitamin D
Ergocalciferols
Ritonavir
Darunavir
Raltegravir Potassium
Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

ClinicalTrials.gov processed this data on October 23, 2017
This information is provided by ClinicalTrials.gov.