NCT01343225

Brief Summary

2\. Objectives

  1. 1.To determine the vitamin D status of African-American HIV patients who are HIV-treatment naïve.
  2. 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. 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. 4.To compare the efficacy of an alternative regimen (raltegravir, darunavir, ritonavir) to a standard once-daily regimen (tenofovir-emtricitabine-efavirenz).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4 hiv

Timeline
Completed

Started May 2011

Typical duration for phase_4 hiv

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 28, 2011

Completed
3 days until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

April 28, 2011

Status Verified

April 1, 2011

Enrollment Period

3 years

First QC Date

April 26, 2011

Last Update Submit

April 27, 2011

Conditions

HIV

Keywords

African american vitamin d bone densityAfrican American male or female treatment naive

Outcome Measures

Primary Outcomes (1)

  • Vitamin D levels and bone density

    collection of vitamin d levels and bone density measured before and at end of 48 weeks

    48 weeks

Secondary Outcomes (1)

  • viral load and CD 4 count

    48 weeks

Study Arms (2)

atripla

ACTIVE COMPARATOR

comparator

Drug: atripla

darunavir ritonavir raltegravir

EXPERIMENTAL

experimental

Drug: darunavir ritonavir raltegravir

Interventions

atriplaDRUG

once a day

atripla
darunavir ritonavir raltegravirDRUG

as directed

darunavir ritonavir raltegravir

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • age between 18 and 50 years old
  • HIV infection and HIV RNA \> 4000 copies/ml of plasma

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Intervention Hierarchy (Ancestors)

TenofovirOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsOxazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsEmtricitabineDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesAdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingDrug CombinationsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 26, 2011

First Posted

April 28, 2011

Study Start

May 1, 2011

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

April 28, 2011

Record last verified: 2011-04