HIV InfectionNCT00096746
Effect of the Atazanavir (ATV) 150L Mutation on Subsequent Treatment Response in HIV Infected Subjects
An observational study of HIV Infection, run by Bristol-Myers Squibb at 37 sites in 7 countries.
Trial summary
This study will compare the response of subjects who failed a first-line ATV-containing regimen and who have the 150L-containing virus to subsequent protease inhibitor (PI)-containing therapy with that of a cohort who has failed a first-line reverse transcriptase inhibitor (NNRTI), and is subsequently receiving… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infection
- What is being tested?
- LPV/RTV + 2NRTIs
- Type of treatment
- Pill or oral medicine
- How many people
- 200 participants
- Where
- 37 sitesin 7 countries
- Study dates
- Nov 2004to Sep 2006
- Phase
- Observational
- 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
Study population: HIV infected individuals on first line ATV based HAART with presence of I50L mutation \& HIV infected PI naïve on failed NNRTI based regimen.
Who may be able to join
- Currently on a first-line antiretroviral regimen containing ATV with a confirmed rebound and a genotype that verifies the presence of an 150L mutation OR on a first-line regimen containing an NNRTI and PI-naive, with a confirmed rebound
Who cannot join
- Women of child bearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the study.
- Women who are pregnant or breastfeeding.
- A life expectancy of <12 months.
- Presence of a newly diagnosed HIV-related opportunistic infection or any other medical condition requiring acute therapy at the time of enrollment.
- Active alcohol or substance abuse sufficient, in the investigator's opinion, to prevent adequate adherence to study therapy or to increase the risk of developing pancreatitis or chemical hepatitis.
Trial locations and contacts
37 sites in 7 countries.
37 sites in 7 countries
United States13 sites
Local Institution
Albany, New York
Local Institution
Altamonte Springs, Florida
Local Institution
Dallas, Texas
Local Institution
East Orange, New Jersey
Local Institution
Fort Lauderdale, Florida
Local Institution
Honolulu, Hawaii
Local Institution
Huntersville, North Carolina
Local Instution
Lexington, Kentucky
Local Institution
Louisville, Kentucky
Local Institution
Phoenix, Arizona
Local Institution
Portland, Oregon
Local Institution
Vero Beach, Florida
Local Instution
Wichita, Kansas
South Africa8 sites
Local Institution
Bedford Gardens, Gauteng
Local Institution
Bloemfontein, Free State
Local Institution
Johannesburg, Gauteng
Local Institution
Meadowdale, Gauteng
Local Institution
Mowbray, Western Cape
Local Institution
Port Elizabeth, Eastern Cape
Local Institution
Rugby, Western Cape
Local Institution
Westdene, Gauteng
Argentina7 sites
Local Institution
Buenos Aires, Buenos Aires
Local Institution
Buenos Aires
Local Institution
Capital Federal, Buenos Aires
Local Institution
Córdoba, Córdoba Province
Local Institution
La Plata, Buenos Aires
Local Institution
Mar del Plata, Buenos Aires
Local Institution
Rosario, Santa Fe Province
Brazil5 sites
Local Institution
Campinas, São Paulo
Local Institution
Curitiba, Paraná
Local Institution
Recife, Pernambuco
Local Institution
Rio de Janeiro, Rio de Janeiro
Local Institution
São Paulo
Mexico2 sites
Local Institution
Durango, Durango
Local Institution
Guadalajara, Jalisco
About this study
Official title: An Exploratory Study of the Effect of the Atazanavir (ATV) I50L Mutation on Subsequent Treatment Response
This study will compare the response of subjects who failed a first-line ATV-containing regimen and who have the 150L-containing virus to subsequent protease inhibitor (PI)-containing therapy with that of a cohort who has failed a first-line reverse transcriptase inhibitor (NNRTI), and is subsequently receiving PI-containing therapy.
- Conditions
- HIV Infection
- Being tested
- LPV/RTV + 2NRTIs
- Keywords
- Treatment Experienced
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LPV/RTV + 2NRTIsDrug
Tablets, Oral, Variable, Twice daily, 48 weeks.
LPV/RTV + 2NRTIsDrug
Tablets, Oral, Variable, Twice daily, 48 weeks.
| Study group | Role | What they receive |
|---|---|---|
| A1 | HIV infected individuals on first line ATV based HAART with presence of I50L mutation. Receives: Drug: LPV/RTV + 2NRTIs | |
| A2 | HIV infected PI naïve on failed NNRTI based regimen. Receives: Drug: LPV/RTV + 2NRTIs |
What is being measured
The primary outcome is the main question the study is designed to answer.
The log10 HIV RNA change from baseline for each cohort.
Measured: through Week 48
Secondary outcomes (1)
Evaluate proportion of patients with plasma HIV RNA <50 copies/mL
Measured: at Weeks 24, 48, 72, and 96.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2004 (estimated)
- Study startNov 2004
- Primary completionSep 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bristol-Myers Squibb, Study chair, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00096746
- Sponsor's protocol ID
- AI424-079
- Status last verified
- Apr 2011
- First submitted
- 15 Nov 2004
- Last updated
- 13 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of the Effect of the Atazanavir (ATV) I50L Mutation on Subsequent Treatment Response
- ClinicalTrials.gov ID
- NCT00096746
- Acronym / sponsor ID
- AI424-079
- Conditions
- HIV Infection
- Keywords
- Treatment Experienced
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Nov 2004
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2006
- First posted
- 16 Nov 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.
This study will compare the response of subjects who failed a first-line ATV-containing regimen and who have the 150L-containing virus to subsequent protease inhibitor (PI)-containing therapy with that of a cohort who has failed a first-line reverse transcriptase inhibitor (NNRTI), and is subsequently receiving PI-containing therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A1 | – | Drug: LPV/RTV + 2NRTIsHIV infected individuals on first line ATV based HAART with presence of I50L mutation. |
| A2 | – | Drug: LPV/RTV + 2NRTIsHIV infected PI naïve on failed NNRTI based regimen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV infected individuals on first line ATV based HAART with presence of I50L mutation \& HIV infected PI naïve on failed NNRTI based regimen.
Key inclusion criteria (1 listed)
- Currently on a first-line antiretroviral regimen containing ATV with a confirmed rebound and a genotype that verifies the presence of an 150L mutation OR on a first-line regimen containing an NNRTI and PI-naive, with a confirmed rebound
Key exclusion criteria (5 listed)
- Women of child bearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the study.
- Women who are pregnant or breastfeeding.
- A life expectancy of <12 months.
- Presence of a newly diagnosed HIV-related opportunistic infection or any other medical condition requiring acute therapy at the time of enrollment.
- Active alcohol or substance abuse sufficient, in the investigator's opinion, to prevent adequate adherence to study therapy or to increase the risk of developing pancreatitis or chemical hepatitis.
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 |
|---|---|---|
| LPV/RTV + 2NRTIsTablets, Oral, Variable, Twice daily, 48 weeks. | Drug | A1 |
| LPV/RTV + 2NRTIsTablets, Oral, Variable, Twice daily, 48 weeks. | Drug | A2 |
Primary outcome
The log10 HIV RNA change from baseline for each cohort.
Time frame: through Week 48
1 secondary outcome
Evaluate proportion of patients with plasma HIV RNA <50 copies/mL
Time frame: at Weeks 24, 48, 72, and 96.
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 13 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 chair
Bristol-Myers Squibb
37 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infection, run by Bristol-Myers Squibb at 37 sites in 7 countries.
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 1 inclusion and 5 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 13 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 37 sites in United States, South Africa, Argentina, Brazil, Mexico and 2 more countries. 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.
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?
The log10 HIV RNA change from baseline for each cohort. (time frame: through Week 48). 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 13 Apr 2011.