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 because the information has not been verified recently.

Verified April 2011 by East Carolina University.
Recruitment status was Not yet recruiting

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

To determine the vitamin D status of African-American HIV patients who are HIV-treatment naïve.
To compare the effects of an efavirenz-containing regimen to a protease inhibitor regimen on 25-hydroxyvitamin D and 1,25 dihydroxyvitamin D3 levels.
To compare the effect on bone density of a tenofovir- and efavirenz-containing regimen to a regimen that does not contain these drugs.
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:

MedlinePlus related topics: African American Health Bone Density HIV/AIDS Vitamin D

Drug Information available for: Vitamin D Ritonavir Darunavir Raltegravir Darunavir ethanolate Atripla Raltegravir potassium

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 (Adult)
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

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.

No Contacts or Locations Provided

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
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 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

ClinicalTrials.gov processed this record on September 23, 2016

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