HIV InfectionsPhase 3NCT00135343
A Pilot Study of Atazanavir/Ritonavir/Efavirenz as a Nucleoside Sparing Regimen
A Phase 3 study testing Atazanvir/ritonavir + efavirenz in people with HIV Infections, run by Bristol-Myers Squibb at 15 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of a novel nucleoside sparing regimen containing atazanavir, ritonavir and efavirenz, using two different doses of atazanavir. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Atazanvir/ritonavir + efavirenz
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 15 sitesUnited States
- Study dates
- Apr 2004to Oct 2005
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide written informed consent
- HIV positive with plasma HIV RNA viral load of ≥ 1000 copies/mL and CD4 cell count of ≥ 50 cells/mm3
- Antiretroviral (ARV) naive prior to enrollment
- Normal plasma triglycerides ≤ 200 mg/dL
- Women of child-bearing age must use effective barrier contraception
Who cannot join
- Pregnancy or breast feeding
- Evidence of resistance to antiretroviral drugs
- History of elevated blood cholesterol or triglycerides
- History of diabetes
- Hypersensitivity to any component of the study drugs
- Any cholesterol or triglyceride lowering medications in the past six months
- Use of growth hormone, megestrol acetate, or anabolic steroids in the past six months
- Imprisonment or involuntary incarceration for medical treatment
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Local Institution
Atlantis, Florida
Local Institution
Austin, Texas
Local Institution
Berkley, Michigan
Local Institution
Boston, Massachusetts
Local Institution
Clumbia, South Carolina
Local Institution
Dallas, Texas
Local Institution
Hampton, Virginia
Local Institution
Huntersville, North Carolina
Local Institution
New Orleans, Louisiana
Local Institution
Orlando, Florida
Local Institution
San Francisco, California
Local Institution
South Miami, Florida
Local Institution
St Louis, Missouri
Local Institution
Tampa, Florida
Local Institution
Washington D.C., District of Columbia
About this study
The purpose of this study is to evaluate the safety and efficacy of a novel nucleoside sparing regimen containing atazanavir, ritonavir and efavirenz, using two different doses of atazanavir.
- Conditions
- HIV Infections
- Being tested
- Atazanvir/ritonavir + efavirenz
- Keywords
- HIV/AIDS
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atazanvir/ritonavir + efavirenzDrug
Also called Reyataz & Sustiva
Capsules (ATV and RTV) Tablets (EFV), Oral, ATV 300 mg + RTV 100 mg + EFV 600 mg, Once daily, 48 weeks.
Atazanvir/ritonavir + efavirenzDrug
Also called Reyataz & Sustiva
Capsules (ATV and RTV) Tablets (EFV), Oral ATV 400 mg + RTV 100 mg + EFV 600 mg, Once daily, 48 weeks.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: Atazanvir/ritonavir + efavirenz |
| B | Experimental | Not described Receives: Drug: Atazanvir/ritonavir + efavirenz |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean percent change from baseline in fasting plasma triglycerides at Week 8
Secondary outcomes (2)
Incidence of grade 2-4 elevation of fasting plasma triglycerides at Week (Wk) 8, 24 and 48
The mean percent change from baseline in fasting plasma triglycerides at Wk 24 and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2005 (estimated)
- Study startApr 2004
- Primary completionOct 2005
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- 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 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00135343
- Sponsor's protocol ID
- AI424-121
- Status last verified
- Jul 2008
- First submitted
- 25 Aug 2005
- Last updated
- 14 Apr 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Atazanavir/Ritonavir/Efavirenz as a Nucleoside Sparing Regimen
- ClinicalTrials.gov ID
- NCT00135343
- Acronym / sponsor ID
- AI424-121
- Conditions
- HIV Infections
- Keywords
- HIV/AIDS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- Primary completion
- Oct 2005 (actual)
- Study completion
- Oct 2005
- First posted
- 26 Aug 2005 (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.
The purpose of this study is to evaluate the safety and efficacy of a novel nucleoside sparing regimen containing atazanavir, ritonavir and efavirenz, using two different doses of atazanavir.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Atazanvir/ritonavir + efavirenz |
| B | Experimental | Drug: Atazanvir/ritonavir + efavirenz |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Provide written informed consent
- HIV positive with plasma HIV RNA viral load of ≥ 1000 copies/mL and CD4 cell count of ≥ 50 cells/mm3
- Antiretroviral (ARV) naive prior to enrollment
- Normal plasma triglycerides ≤ 200 mg/dL
- Women of child-bearing age must use effective barrier contraception
Key exclusion criteria (8 listed)
- Pregnancy or breast feeding
- Evidence of resistance to antiretroviral drugs
- History of elevated blood cholesterol or triglycerides
- History of diabetes
- Hypersensitivity to any component of the study drugs
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 |
|---|---|---|
| Atazanvir/ritonavir + efavirenzAlso: Reyataz & SustivaCapsules (ATV and RTV) Tablets (EFV), Oral, ATV 300 mg + RTV 100 mg + EFV 600 mg, Once daily, 48 weeks. | Drug | A |
| Atazanvir/ritonavir + efavirenzAlso: Reyataz & SustivaCapsules (ATV and RTV) Tablets (EFV), Oral ATV 400 mg + RTV 100 mg + EFV 600 mg, Once daily, 48 weeks. | Drug | B |
Primary outcome
Mean percent change from baseline in fasting plasma triglycerides at Week 8
2 secondary outcomes
Incidence of grade 2-4 elevation of fasting plasma triglycerides at Week (Wk) 8, 24 and 48
The mean percent change from baseline in fasting plasma triglycerides at Wk 24 and 48
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2011.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Atazanvir/ritonavir + efavirenz in people with HIV Infections, run by Bristol-Myers Squibb at 15 sites in United States.
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 5 inclusion and 8 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: finished, as of the sponsor's last update on 14 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean percent change from baseline in fasting plasma triglycerides at Week 8. 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 14 Apr 2011.