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

HIV Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01343225
• Other study ID #: IISP # 38879
• Status: Not yet recruiting
• Phase: Phase 4
• First received: April 26, 2011
• Last updated: April 27, 2011
• Start date: May 2011
• Est. completion date: May 2014

Study information

• Verified date: April 2011
• Source: East Carolina University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• HIV
• HIV Infections

Intervention

Drug:
• atripla
once a day
• darunavir ritonavir raltegravir
as directed

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
East Carolina University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vitamin D levels and bone density	collection of vitamin d levels and bone density measured before and at end of 48 weeks	48 weeks	Yes
Secondary	viral load and CD 4 count	Viral load and CD 4 at baseline and 48 weeks	48 weeks	Yes