HIV InfectionsPhase 4NCT00084253
Study of Boosted Atazanavir (ATV) Versus Non-boosted ATV in Naive Patients
A Phase 4 study testing Atazanavir/ Stavidine / Lamivudine and Atazanavir-Ritonavir/ Stavidine / Lamivudine in people with HIV Infections, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this study is to find out if 300 mg of ATV plus 100 mg of ritonavir (RTV) works as well as 400 mg of ATV alone as part of a regimen with stavudine XR and lamivudine to slow or stop the progression of HIV infection in patients who have never used anti-HIV drugs. 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?
- Atazanavir/ Stavidine / Lamivudine and Atazanavir-Ritonavir/ Stavidine / Lamivudine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to Aug 2006
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Informed Consent
- HIV RNA greater than or equal 200 copies/mL at screening
- 18 years old or older
- Must use barrier contraception
- Women of child-bearing potential must have a negative serum or urine pregnancy test within 72 hours before beginning to take the study medications
Who cannot join
- Unable or unwilling to use acceptable method of birth control for the entire study period including 8 weeks after the study
- Women using oral contraceptives, pregnant or breastfeeding women
- Women who have a positive pregnancy test on enrollment or before beginning to take the study medications
- People who have a life expectancy of greater than 12 months
- Newly diagnosed HIV-related OI or any medical condition requiring acute therapy at the time of enrollment
- Any antiretroviral therapy within 30 days prior to screening
Show all 12Show fewer
- Any prior antiretroviral therapy (greater than 30 days of NRTI and/or greater than 7 days of non-nucleoside reverse-transcriptase inhibitor (NNRTI) or protease inhibitor therapies)
- Any of the following conditions: Cushings Syndrome, Gilbert's Syndrome, untreated hypothyroidism or hyperthyroidism, suspected primary (acute) HIV infection, obstructive liver disease, proven or suspected acute hepatitis in the 30 days prior to study entry, Intractable diarrhea (at greater than 6 loose stools per day for at least 78 consecutive days) within 30 days prior to study entry, history of hemophilia, history of acute or chronic pancreatitis, presence of cardiomyopathy (due to any cause) or any significant cardiovascular disease, such as unstable ischemic heart disease
- Active alcohol or substance abuse
- History or signs and symptoms of bilateral peripheral neuropathy greater than grade 2 at the time of screening
- Previous therapy with myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic, or cytotoxic potential within 3 months of study start or the expected need for such therapy or therapy with methadone or ribavirin/interferons or treatment with neurotoxic drugs or drugs that affect CYP3A4
- Inability to swallow capsules
Trial locations and contacts
1 site in 1 country.
United States1 site
Various locations within the US
Call For Information, New Jersey
About this study
Official title: Phase IV Study of Boosted Atazanavir (ATV) Versus Non-boosted ATV in Naive Patients
The purpose of this study is to find out if 300 mg of ATV plus 100 mg of ritonavir (RTV) works as well as 400 mg of ATV alone as part of a regimen with stavudine XR and lamivudine to slow or stop the progression of HIV infection in patients who have never used anti-HIV drugs.
- Conditions
- HIV Infections
- Being tested
- Atazanavir/ Stavidine / Lamivudine, Atazanavir-Ritonavir/ Stavidine / Lamivudine
- Keywords
- HIV, Treatment Naive
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atazanavir/ Stavidine / LamivudineDrug
Also called Reyataz
Capsules, Oral, ATV (2 x 200 mg) QD + 3TC (2 x 150 mg) QD + Zerit XR (1 x 100 mg) QD, Once daily, 96 weeks.
Atazanavir-Ritonavir/ Stavidine / LamivudineDrug
Also called Reyataz
Capsules, Oral, ATV (2 x 150 mg) QD + RTV (1 x 100 mg) QD + 3TC (2 x 150 mg) QD + Zerit XR (1 x 100 mg) QD*, Once daily, 96 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: Atazanavir/ Stavidine / Lamivudine |
| 2 | Active comparator | Not described Receives: Drug: Atazanavir-Ritonavir/ Stavidine / Lamivudine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the proportion of subjects responding to treatment with HIV RNA levels < LOQ (400 c/mL) through Week 48 in treatment naive subjects for ATV and ATV/RTV (each combined with 3TC and d4T XR).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2004 (estimated)
- Study startJun 2004
- Primary completionAug 2006
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
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
- NCT00084253
- Sponsor's protocol ID
- AI424-089 ST
- Status last verified
- Jun 2008
- First submitted
- 9 Jun 2004
- Last updated
- 5 Mar 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Study of Boosted Atazanavir (ATV) Versus Non-boosted ATV in Naive Patients
- ClinicalTrials.gov ID
- NCT00084253
- Acronym / sponsor ID
- AI424-089 ST
- Conditions
- HIV Infections
- Keywords
- HIV, Treatment Naive
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Jun 2004
- Primary completion
- Aug 2006 (actual)
- First posted
- 11 Jun 2004 (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 find out if 300 mg of ATV plus 100 mg of ritonavir (RTV) works as well as 400 mg of ATV alone as part of a regimen with stavudine XR and lamivudine to slow or stop the progression of HIV infection in patients who have never used anti-HIV drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Atazanavir/ Stavidine / Lamivudine |
| 2 | Active comparator | Drug: Atazanavir-Ritonavir/ Stavidine / Lamivudine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed Informed Consent
- HIV RNA greater than or equal 200 copies/mL at screening
- 18 years old or older
- Must use barrier contraception
- Women of child-bearing potential must have a negative serum or urine pregnancy test within 72 hours before beginning to take the study medications
Key exclusion criteria (12 listed)
- Unable or unwilling to use acceptable method of birth control for the entire study period including 8 weeks after the study
- Women using oral contraceptives, pregnant or breastfeeding women
- Women who have a positive pregnancy test on enrollment or before beginning to take the study medications
- People who have a life expectancy of greater than 12 months
- Newly diagnosed HIV-related OI or any medical condition requiring acute therapy at the time of enrollment
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 |
|---|---|---|
| Atazanavir/ Stavidine / LamivudineAlso: ReyatazCapsules, Oral, ATV (2 x 200 mg) QD + 3TC (2 x 150 mg) QD + Zerit XR (1 x 100 mg) QD, Once daily, 96 weeks. | Drug | 1 |
| Atazanavir-Ritonavir/ Stavidine / LamivudineAlso: ReyatazCapsules, Oral, ATV (2 x 150 mg) QD + RTV (1 x 100 mg) QD + 3TC (2 x 150 mg) QD + Zerit XR (1 x 100 mg) QD*, Once daily, 96 weeks. | Drug | 2 |
Primary outcome
To compare the proportion of subjects responding to treatment with HIV RNA levels < LOQ (400 c/mL) through Week 48 in treatment naive subjects for ATV and ATV/RTV (each combined with 3TC and d4T XR).
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 5 Mar 2010.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atazanavir/ Stavidine / Lamivudine and Atazanavir-Ritonavir/ Stavidine / Lamivudine in people with HIV Infections, run by Bristol-Myers Squibb at 1 site 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 12 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 5 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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?
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?
To compare the proportion of subjects responding to treatment with HIV RNA levels < LOQ (400 c/mL) through Week 48 in treatment naive subjects for ATV and ATV/RTV (each combined with 3TC and d4T XR).. 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 5 Mar 2010.