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

University of North Carolina System

Status and phase: Unknown; Phase 4

Conditions: HIV

Treatments: Drug: darunavir ritonavir raltegravir; Drug: atripla

Study type: Interventional

Funder types: Other

Identifiers

NCT01343225

IISP # 38879

Details and patient eligibility

About

2. Objectives

3. To determine the vitamin D status of African-American HIV patients who are HIV-treatment naïve.

4. To compare the effects of an efavirenz-containing regimen to a protease inhibitor regimen on 25-hydroxyvitamin D and 1,25 dihydroxyvitamin D3 levels.

5. To compare the effect on bone density of a tenofovir- and efavirenz-containing regimen to a regimen that does not contain these drugs.

6. 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

atripla

Active Comparator group

Description:

comparator

Treatment:

Drug: atripla

darunavir ritonavir raltegravir

Experimental group

Description:

experimental

Treatment:

Drug: darunavir ritonavir raltegravir