HIV InfectionsPhase 3NCT00135382
Study Switching HIV-1 Infected Patients With an Undetectable Viral Load on a First Protease Inhibitor-Based Regimen to an Efavirenz-Based Regimen
A Phase 3 study testing Videx EC, Epivir and Sustiva in people with HIV Infections, run by Bristol-Myers Squibb at 48 sites in 2 countries.
Trial summary
The purpose of this study is to demonstrate that virologically controlled HIV-infected individuals can successfully switch from a protease inhibitor (PI)-based regimen to an efavirenz-based regimen while maintaining virologic control, as evaluated by the proportion of subjects who continue to have plasma HIV-1 levels… 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?
- Videx EC, Epivir and Sustiva
- How many people
- 254 participants
- Where
- 48 sitesin 2 countries
- Study dates
- Jun 2002to 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
- Documented HIV infection
- ≥ 18 years of age and weight at least 40kg
- Two plasma HIV RNA levels < 50 copies/mL during the qualification and screening period
- Patients receiving a PI and ≥ 2 NRTIs
Who cannot join
- Pregnancy or breastfeeding
- Documented virologic failure while on their first PI-based antiretroviral (ARV) regimen
- Active AIDS-defining opportunistic infection or disease
- Proven or suspected acute hepatitis within 30 days prior to study entry
Trial locations and contacts
48 sites in 2 countries.
48 sites in 2 countries
United States46 sites
Local Institution
Atlanta, Georgia
Local Institution
Atlantis, Florida
Local Institution
Austin, Texas
Local Institution
Beverly Hills, California
Local Institution
Boston, Massachusetts
Local Institution
Brooklyn, New York
Local Institution
Chicago, Illinois
Local Institution
Columbia, South Carolina
Local Institution
Dallas, Texas
Local Institution
Daytona Beach, Florida
Local Institution
Decatur, Georgia
Local Institution
Denver, Colorado
Local Institution
East Orange, New Jersey
Local Institution
Fort Lauderdale, Florida
Local Institution
Fountain Valley, California
Local Institution
Hampton, Virginia
Local Institution
Jacksonville, Florida
Local Institution
Kansas City, Missouri
Local Institution
Little Rock, Arkansas
Local Institution
Long Beach, California
Local Institution
Los Angeles, California
Local Institution
Manhasset, New York
Local Institution
Miami, Florida
Local Institution
Miami Beach, Florida
Local Institution
Milwaukee, Wisconsin
Local Institution
Mount Vernon, New York
Local Institution
New York, New York
Local Institution
Newark, New Jersey
Local Institution
North Miami, Florida
Local Institution
Norwalk, Connecticut
Local Institution
Orlando, Florida
Local Institution
Philadelphia, Pennsylvania
Local Institution
Plantation, Florida
Local Institution
Safety Harbor, Florida
Local Institution
San Diego, California
Local Institution
San Francisco, California
Local Institution
South Miami, Florida
Local Institution
Springfield, Massachusetts
Local Institution
St Louis, Missouri
Local Institution
Stony Brook, New York
Local Institution
Tampa, Florida
Local Institution
Tarzana, California
Local Institution
Union, New Jersey
Local Institution
Valhalla, New York
Local Institution
Washington D.C., District of Columbia
Local Institution
West Hollywood, California
About this study
Official title: A Phase 3 Study Switching HIV-1 Infected Patients With an Undetectable Viral Load on a First Protease Inhibitor-Based Regimen to an Efavirenz-Based Regimen
The purpose of this study is to demonstrate that virologically controlled HIV-infected individuals can successfully switch from a protease inhibitor (PI)-based regimen to an efavirenz-based regimen while maintaining virologic control, as evaluated by the proportion of subjects who continue to have plasma HIV-1 levels < 50 copies/mL. In addition, a simplified once-daily regimen will improve adherence and quality of life.
Read the detailed description
Patients randomized to the non Videx enteric coated (ddl EC)+lamivudine (3TC)+efavirenz (EFV) arm would continue their baseline nucleoside reverse transcriptase inhibitors (NRTIs) on study.
- Conditions
- HIV Infections
- Being tested
- Videx EC, Epivir, Sustiva
- 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.
Videx ECDrug
EpivirDrug
SustivaDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy at week 48
Secondary outcomes (1)
Safety, tolerability and efficacy at weeks (wks) 24 and 48; Effect on lipids at wks 24 and 48; Adherence, quality of life changes, treatment satisfaction and preference at wks 12, 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 startJun 2002
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 254 participants
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00135382
- Sponsor's protocol ID
- AI266-406
- Status last verified
- Jan 2010
- First submitted
- 25 Aug 2005
- Last updated
- 17 Feb 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Study Switching HIV-1 Infected Patients With an Undetectable Viral Load on a First Protease Inhibitor-Based Regimen to an Efavirenz-Based Regimen
- ClinicalTrials.gov ID
- NCT00135382
- Acronym / sponsor ID
- AI266-406
- Conditions
- HIV Infections
- Keywords
- HIV/AIDS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 254 participants
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Jun 2002
- Primary completion
- Oct 2005 (actual)
- Study completion
- Oct 2005 (actual)
- 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 demonstrate that virologically controlled HIV-infected individuals can successfully switch from a protease inhibitor (PI)-based regimen to an efavirenz-based regimen while maintaining virologic control, as evaluated by the proportion of subjects who continue to have plasma HIV-1 levels < 50 copies/mL. In addition, a simplified once-daily regimen will improve adherence and quality of life.
Detailed description
Patients randomized to the non Videx enteric coated (ddl EC)+lamivudine (3TC)+efavirenz (EFV) arm would continue their baseline nucleoside reverse transcriptase inhibitors (NRTIs) on study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Documented HIV infection
- ≥ 18 years of age and weight at least 40kg
- Two plasma HIV RNA levels < 50 copies/mL during the qualification and screening period
- Patients receiving a PI and ≥ 2 NRTIs
Key exclusion criteria (4 listed)
- Pregnancy or breastfeeding
- Documented virologic failure while on their first PI-based antiretroviral (ARV) regimen
- Active AIDS-defining opportunistic infection or disease
- Proven or suspected acute hepatitis within 30 days prior to study entry
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 |
|---|---|---|
| Videx EC | Drug | – |
| Epivir | Drug | – |
| Sustiva | Drug | – |
Primary outcome
Efficacy at week 48
1 secondary outcome
Safety, tolerability and efficacy at weeks (wks) 24 and 48; Effect on lipids at wks 24 and 48; Adherence, quality of life changes, treatment satisfaction and preference at wks 12, 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 17 Feb 2010.
Related trials for HIV Infections
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.
48 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Videx EC, Epivir and Sustiva in people with HIV Infections, run by Bristol-Myers Squibb at 48 sites in 2 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 4 inclusion and 4 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 17 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in United States, Puerto Rico. 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?
Efficacy at 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 17 Feb 2010.