HIV InfectionsPhase 3NCT00135369

Switching HIV-1 Infected Subjects From a Highly Active Anti-Retroviral Treatment (HAART) Regimen Dosed Twice Daily or More Frequently to a Once-Daily Regimen

A Phase 3 study testing stavudine extended-release, lamivudine, efavirenz in people with HIV Infections, run by Bristol-Myers Squibb at 47 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to demonstrate that virologically controlled HIV-infected individuals can successfully switch from a standard-of-care regimen dosed twice-daily or more frequently to a simpler once-daily (QD) regimen while maintaining virologic control, as evaluated by the proportion of subjects who… 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?: stavudine extended-release, lamivudine, efavirenz
How many people: 300 participants
Where: 47 sitesin 2 countries
Study dates: Sep 2002to Jul 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 or older and weigh at least 40 kg
Two plasma HIV RNA levels below the limit of quantification (one at least 90 days prior to the screening visit and one within 30 days of the patients baseline visit)
Currently receiving a standard-of-care HAART regimen with at least one agent being dosed twice-daily or more frequently

Who cannot join

Pregnancy, breastfeeding or plans to become pregnant during the study period
Any prior documented virologic failure to one or more HAART regimens
Active AIDS-defining opportunistic infection or disease
Proven or suspected acute hepatitis within 30 days prior to study entry

Trial locations and contacts

47 sites in 2 countries.

Country

City, postcode or hospital

47 sites in 2 countries

United States46 sites

Local Institution
Annandale, Virginia
Local Institution
Baltimore, Maryland
Local Institution
Berkley, Michigan
Local Institution
Boston, Massachusetts
Local Institution
Charlotte, North Carolina
Local Institution
Chicago, Illinois
Local Institution
Dallas, Texas
Local Institution
Decatur, Georgia
Local Institution
Denver, Colorado
Local Institution
Detroit, Michigan
Local Institution
Fort Lauderdale, Florida
Local Institution
Galveston, Texas
Local Institution
Hackensack, New Jersey
Local Institution
Hampton, Virginia
Local Institution
Hobson City, Alabama
Local Institution
Houston, Texas
Local Institution
Huntersville, North Carolina
Local Institution
Indianapolis, Indiana
Local Institution
Jersey City, New Jersey
Local Institution
Las Vegas, Nevada
Local Institution
Little Rock, Arkansas
Local Institution
Los Angeles, California
Local Institution
Manhasset, New York
Local Institution
Miami, Florida
Local Institution
Miami Beach, Florida
Local Institution
Montgomery, Alabama
Local Institution
Neptune City, New Jersey
Local Institution
New Orleans, Louisiana
Local Institution
New York, New York
Local Institution
Norwalk, Connecticut
Local Institution
Pensacola, Florida
Local Institution
Philadelphia, Pennsylvania
Local Institution
Phoenix, Arizona
Local Institution
Reading, Pennsylvania
Local Institution
Sacramento, California
Local Institution
San Mateo, California
Local Institution
Seattle, Washington
Local Institution
Somers Point, New Jersey
Local Institution
St Louis, Missouri
Local Institution
Stratford, Connecticut
Local Institution
Tampa, Florida
Local Institution
The Bronx, New York
Local Institution
Torrance, California
Local Institution
Washington, North Carolina
Local Institution
Washington D.C., District of Columbia
Local Institution
Winston-Salem, North Carolina

Other trials in United States

Puerto Rico1 site

Local Institution
San Juan

Other trials in Puerto Rico

About this study

Official title: A Phase 3 Study Switching HIV-1 Infected Subjects With an Undetectable Viral Load From a HAART Regimen Dosed Twice Daily or More Frequently to a Once-Daily HAART Regimen

Conditions: HIV Infections
Being tested: stavudine extended-release, lamivudine, 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.

stavudine extended-release, lamivudine, efavirenzDrug

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.

Sep 2002Jul 2005

First posted26 Aug 2005 (estimated)
Study startSep 2002
Primary completionJul 2005
Study completionJul 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: 300 participants

IDs, dates and publications

ClinicalTrials.gov ID: NCT00135369
Sponsor's protocol ID: AI455-135
Status last verified: Apr 2011
First submitted: 25 Aug 2005
Last updated: 25 Apr 2011
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All HIV Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3 Study Switching HIV-1 Infected Subjects With an Undetectable Viral Load From a HAART Regimen Dosed Twice Daily or More Frequently to a Once-Daily HAART Regimen
ClinicalTrials.gov ID: NCT00135369
Acronym / sponsor ID: AI455-135
Conditions: HIV Infections
Keywords: HIV-AIDS
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 300 participants
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Study start: Sep 2002
Primary completion: Jul 2005 (actual)
Study completion: Jul 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.

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 or older and weigh at least 40 kg
Two plasma HIV RNA levels below the limit of quantification (one at least 90 days prior to the screening visit and one within 30 days of the patients baseline visit)
Currently receiving a standard-of-care HAART regimen with at least one agent being dosed twice-daily or more frequently

Key exclusion criteria (4 listed)

Pregnancy, breastfeeding or plans to become pregnant during the study period
Any prior documented virologic failure to one or more HAART regimens
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
stavudine extended-release, lamivudine, efavirenz	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 25 Apr 2011.

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
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Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
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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.

The record lists no contact. Use the official record to reach the sponsor.

47 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 stavudine extended-release, lamivudine, efavirenz in people with HIV Infections, run by Bristol-Myers Squibb at 47 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 25 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 47 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?

On the ClinicalTrials.gov record for NCT00135369.

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 25 Apr 2011.