Effect of a Non-tenofovir, Non-efavirenz-based HIV Regimen on Bone Density and Vitamin D Levels in African-American Patients With HIV Infection

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

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.

Study Overview

• Status: Unknown
• Conditions: HIV
• Intervention / Treatment: Drug: atripla; Drug: darunavir ritonavir raltegravir

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: atripla; comparator	Drug: atripla; once a day
Experimental: darunavir ritonavir raltegravir; experimental	Drug: darunavir ritonavir raltegravir; as directed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vitamin D levels and bone density	collection of vitamin d levels and bone density measured before and at end of 48 weeks	48 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
viral load and CD 4 count	Viral load and CD 4 at baseline and 48 weeks	48 weeks

Collaborators and Investigators

• Sponsor: East Carolina University

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Anticipated): May 1, 2014
• Study Completion (Anticipated): May 1, 2014

Study Registration Dates

• First Submitted: April 26, 2011
• First Submitted That Met QC Criteria: April 27, 2011
• First Posted (Estimate): April 28, 2011

Study Record Updates

• Last Update Posted (Estimate): April 28, 2011
• Last Update Submitted That Met QC Criteria: April 27, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Keywords: African american vitamin d bone density; African American male or female treatment naive
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Protease Inhibitors; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; HIV Integrase Inhibitors; Integrase Inhibitors; HIV Protease Inhibitors; Viral Protease Inhibitors; Raltegravir Potassium; Ritonavir; Darunavir; Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
• Other Study ID Numbers: IISP # 38879