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Effect of a Non-tenofovir, Non-efavirenz-based HIV Regimen on Bone Density and Vitamin D Levels in African-American Patients With HIV Infection
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2011 by East Carolina University.
Recruitment status was: Not yet recruiting
Recruitment status was: Not yet recruiting
Sponsor:
East Carolina University
Information provided by:
East Carolina University
ClinicalTrials.gov Identifier:
NCT01343225
First received: April 26, 2011
Last updated: April 27, 2011
Last verified: April 2011
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Purpose
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 | Intervention | Phase |
|---|---|---|
| HIV | Drug: atripla Drug: darunavir ritonavir raltegravir | Phase 4 |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by East Carolina University:
Primary Outcome Measures:
- 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:
- viral load and CD 4 count [ Time Frame: 48 weeks ]Viral load and CD 4 at baseline and 48 weeks
| Estimated Enrollment: | 40 |
| Study Start Date: | May 2011 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: atripla
comparator
|
Drug: atripla
once a day
|
|
Experimental: darunavir ritonavir raltegravir
experimental
|
Drug: darunavir ritonavir raltegravir
as directed
|
Eligibility| 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
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No Contacts or Locations Provided
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 |
| Study First Received: | April 26, 2011 |
| Last Updated: | April 27, 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 Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Vitamins Vitamin D Ergocalciferols Ritonavir |
Darunavir Raltegravir Potassium Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Micronutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on September 21, 2017