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 Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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HIV

Intervention / Treatment
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* Drug: atripla
* Drug: darunavir ritonavir raltegravir


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: atripla<br>comparator | Drug: atripla<br>* once a day<br>|
| Experimental: darunavir ritonavir raltegravir<br>experimental | Drug: darunavir ritonavir raltegravir<br>* as directed<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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African american vitamin d bone density, African American male or female treatment naive