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

NCT ID: NCT01343225

Last Updated: 2011-04-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2014-05-31

Brief 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.

Conditions

HIV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

atripla

comparator

Group Type: ACTIVE_COMPARATOR

atripla

Intervention Type: DRUG

once a day

darunavir ritonavir raltegravir

experimental

Group Type: EXPERIMENTAL

darunavir ritonavir raltegravir

Intervention Type: DRUG

as directed

Interventions

atripla

once a day

Intervention Type: DRUG

darunavir ritonavir raltegravir

as directed

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

East Carolina University

OTHER

Sponsor Role: lead

Responsible Party

East Carolina University

Other Identifiers

IISP # 38879

Identifier Type: -

Identifier Source: org_study_id