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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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01343225
Enrollment
40
Registered
2011-04-28
Start date
2011-05-31
Completion date
2014-05-31
Last updated
2011-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

Keywords

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

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.

Interventions

once a day

DRUGdarunavir ritonavir raltegravir

as directed

Sponsors

East Carolina University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Vitamin D levels and bone density48 weekscollection of vitamin d levels and bone density measured before and at end of 48 weeks

Secondary

MeasureTime frameDescription
viral load and CD 4 count48 weeksViral load and CD 4 at baseline and 48 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026