HIVPhase 4NCT01343225
Effect of a Non-tenofovir, Non-efavirenz-based HIV Regimen on Bone Density and Vitamin D Levels in African-American Patients With HIV Infection
A Phase 4 study testing atripla and darunavir ritonavir raltegravir in people with HIV, run by East Carolina University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- HIV
- What is being tested?
- atripla and darunavir ritonavir raltegravir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- May 2011to May 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age between 18 and 50 years old
- HIV infection and HIV RNA > 4000 copies/ml of plasma
Who cannot join
- 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
About this study
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
- 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.
- Conditions
- HIV
- Being tested
- atripla, darunavir ritonavir raltegravir
- Keywords
- African american vitamin d bone density, African American male or female treatment naive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atriplaDrug
once a day
darunavir ritonavir raltegravirDrug
as directed
| Study group | Role | What they receive |
|---|---|---|
| atripla | Active comparator | comparator Receives: Drug: atripla |
| darunavir ritonavir raltegravir | Experimental | experimental Receives: Drug: darunavir ritonavir raltegravir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin D levels and bone density
collection of vitamin d levels and bone density measured before and at end of 48 weeks
Measured: 48 weeks
Secondary outcomes (1)
viral load and CD 4 count
Viral load and CD 4 at baseline and 48 weeks
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2011 (estimated)
- Study startMay 2011
- Primary completionMay 2014 (estimated)
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- East Carolina University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01343225
- Sponsor's protocol ID
- IISP # 38879
- Status last verified
- Apr 2011
- First submitted
- 26 Apr 2011
- Last updated
- 28 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01343225
- Acronym / sponsor ID
- IISP # 38879
- Conditions
- HIV
- Keywords
- African american vitamin d bone density, African American male or female treatment naive
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- East Carolina UniversityUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- May 2014 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 28 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| atripla | Active comparator | Drug: atriplacomparator |
| darunavir ritonavir raltegravir | Experimental | Drug: darunavir ritonavir raltegravirexperimental |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- age between 18 and 50 years old
- HIV infection and HIV RNA > 4000 copies/ml of plasma
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| atriplaonce a day | Drug | atripla |
| darunavir ritonavir raltegraviras directed | Drug | darunavir ritonavir raltegravir |
Primary outcome
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
1 secondary outcome
viral load and CD 4 count
Time frame: 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2011.
Related trials for HIV
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing atripla and darunavir ritonavir raltegravir in people with HIV, run by East Carolina University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vitamin D levels and bone density (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2011.