HIV
Conditions
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
as directed
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Vitamin D levels and bone density | 48 weeks | collection of vitamin d levels and bone density measured before and at end of 48 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| viral load and CD 4 count | 48 weeks | Viral load and CD 4 at baseline and 48 weeks |