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

• ClinicalTrials.gov Identifier: NCT01343225
• Recruitment Status: Unknown
• First Posted: April 28, 2011
• Last Update Posted: April 28, 2011
• Sponsor: East Carolina University
• Information provided by: East Carolina University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
HIV	Drug: atripla; Drug: darunavir ritonavir raltegravir	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• 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
• Study Start Date: May 2011
• Estimated Primary Completion Date: May 2014
• Estimated Study Completion Date: May 2014

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: atripla; comparator	Drug: atripla; once a day
Experimental: darunavir ritonavir raltegravir; experimental	Drug: darunavir ritonavir raltegravir; as directed

Outcome Measures

Primary Outcome Measures :

1. Vitamin D levels and bone density [ Time Frame: 48 weeks ]
   collection of vitamin d levels and bone density measured before and at end of 48 weeks

Secondary Outcome Measures :

1. viral load and CD 4 count [ Time Frame: 48 weeks ]
   Viral load and CD 4 at baseline and 48 weeks

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Paul Cook, East Carolina University
• ClinicalTrials.gov Identifier: NCT01343225 History of Changes
• Other Study ID Numbers: IISP # 38879
• First Posted: April 28, 2011
• Last Update Posted: April 28, 2011
• Last Verified: April 2011

Keywords provided by East Carolina University:

African american vitamin d bone density; African American male or female treatment naive

Additional relevant MeSH terms:

HIV Infections; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Vitamin D; Ergocalciferols; Vitamins; Ritonavir; Darunavir; Raltegravir Potassium; Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Micronutrients; Nutrients; Growth Substances; Physiological Effects of Drugs; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; HIV Protease Inhibitors; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Anti-HIV Agents; Anti-Retroviral Agents; Antiviral Agents; Anti-Infective Agents