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

Sponsor

East Carolina University (Other)

Overall Status

Unknown status

CT.gov ID

NCT01343225

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
HIV	Drug: atripla Drug: darunavir ritonavir raltegravir	Phase 4

Study Design

Study Type:

Interventional

Anticipated 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 1, 2011

Anticipated Primary Completion Date :

May 1, 2014

Anticipated Study Completion Date :

May 1, 2014

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

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

Vitamin D levels and bone density [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 [48 weeks]
Viral load and CD 4 at baseline and 48 weeks

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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