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
- 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).
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|
|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|
Active Comparator: atripla
once a day
Experimental: darunavir ritonavir raltegravir
Drug: darunavir ritonavir raltegravir
- 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