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

• Status: Unknown status
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: East Carolina University
• Treatments: Darunavir; Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Ergocalciferols; Raltegravir Potassium; Ritonavir; Vitamin D; Vitamins

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