Effect of a Non-tenofovir, Non-efavirenz-based HIV Regimen on Bone Density and Vitamin D Levels in African-American Patients With HIV Infection
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ClinicalTrials.gov Identifier: NCT01343225 |
Recruitment Status : Unknown
Verified April 2011 by East Carolina University.
Recruitment status was: Not yet recruiting
First Posted : April 28, 2011
Last Update Posted : April 28, 2011
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2. Objectives
- To determine the vitamin D status of African-American HIV patients who are HIV-treatment naïve.
- To compare the effects of an efavirenz-containing regimen to a protease inhibitor regimen on 25-hydroxyvitamin D and 1,25 dihydroxyvitamin D3 levels.
- To compare the effect on bone density of a tenofovir- and efavirenz-containing regimen to a regimen that does not contain these drugs.
- 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 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 |

Arm | Intervention/treatment |
---|---|
Active Comparator: atripla
comparator
|
Drug: atripla
once a day |
Experimental: darunavir ritonavir raltegravir
experimental
|
Drug: darunavir ritonavir raltegravir
as directed |
- 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
- viral load and CD 4 count [ Time Frame: 48 weeks ]Viral load and CD 4 at baseline and 48 weeks

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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 Key Record Dates |
Last Update Posted: | April 28, 2011 |
Last Verified: | April 2011 |
African american vitamin d bone density African American male or female treatment naive |
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 |