HIV InfectionPhase 3NCT00053638
A New Tablet Containing Two FDA-Approved Drugs In HIV-Infected Patients Who Have Not Received Prior Therapy
A Phase 3 study testing efavirenz, tenofovir and abacavir/lamivudine in people with HIV Infection, run by GlaxoSmithKline at 58 sites in United States.
Trial summary
This is a 48-week study to evaluate the safety and efficacy of a new tablet formulation containing two FDA-approved drugs in HIV-infected patients who have not received prior therapy. This tablet will be taken with one of two FDA-approved drugs as a once-daily regimen. 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?
- efavirenz, tenofovir and abacavir/lamivudine
- How many people
- 345 participants
- Where
- 58 sitesUnited States
- Study dates
- Feb 2003to Oct 2004
- 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
- Participants must be able to provide informed consent.
- Have documented HIV-1 infection.
- Have not received more than 14 days of prior treatment with antiretroviral drugs.
- Meet laboratory test criteria.
- Women of childbearing potential must abstain from sexual intercourse or use acceptable contraception.
- Must be able to take study medications as directed and complete all study visits and evaluations during the 48 week study.
Who cannot join
- Enrolled in other HIV treatment studies.
- Pregnant or breastfeeding.
Trial locations and contacts
58 sites in 1 country.
58 sites in 1 country
United States58 sites
GSK Investigational Site
Albany, New York, 12208
GSK Investigational Site
Albuquerque, New Mexico, 87131-0001
GSK Investigational Site
Atlanta, Georgia, 30309
GSK Investigational Site
Atlanta, Georgia, 30339
GSK Investigational Site
Buffalo, New York, 14215
GSK Investigational Site
Charlotte, North Carolina, 28209
GSK Investigational Site
Chicago, Illinois, 60657
GSK Investigational Site
Cincinnati, Ohio, 45267-0405
GSK Investigational Site
Columbia, South Carolina, 29206-4713
GSK Investigational Site
Dallas, Texas, 75208
GSK Investigational Site
Dallas, Texas, 75246
GSK Investigational Site
Decatur, Georgia, 30033
GSK Investigational Site
Denver, Colorado, 80205
GSK Investigational Site
Denver, Colorado, 80220
GSK Investigational Site
Fort Collins, Colorado, 80528
GSK Investigational Site
Fort Lauderdale, Florida, 33145
GSK Investigational Site
Fort Lauderdale, Florida, 33308
GSK Investigational Site
Fort Lauderdale, Florida, 33316
GSK Investigational Site
Fort Myers, Florida, 33901
GSK Investigational Site
Fort Worth, Texas, 76104
GSK Investigational Site
Fountain Valley, California, 92708
GSK Investigational Site
Green Bay, Wisconsin, 54301
GSK Investigational Site
Hampton, Virginia, 23666
GSK Investigational Site
Hershey, Pennsylvania, 17033
GSK Investigational Site
Hillsborough, New Jersey, 08844
GSK Investigational Site
Houston, Texas, 77030
GSK Investigational Site
Indianapolis, Indiana, 46202 - 5124
GSK Investigational Site
Jacksonville, Florida, 32206
GSK Investigational Site
Los Angeles, California, 90033
GSK Investigational Site
Lynchburg, Virginia, 24501
GSK Investigational Site
Miami, Florida, 33133
GSK Investigational Site
Miami, Florida, 33136
GSK Investigational Site
Minneapolis, Minnesota, 55404
GSK Investigational Site
New Orleans, Louisiana, 70115
GSK Investigational Site
New Orleans, Louisiana, 70127-0800
GSK Investigational Site
New York, New York, 10011
GSK Investigational Site
New York, New York, 10014
GSK Investigational Site
North Miami, Florida, 33161
GSK Investigational Site
Orlando, Florida, 32804
GSK Investigational Site
Orlando, Florida, 32806
GSK Investigational Site
Philadelphia, Pennsylvania, 19102
GSK Investigational Site
Philadelphia, Pennsylvania, 19107
GSK Investigational Site
Phoenix, Arizona, 85006
GSK Investigational Site
Portland, Oregon, 97210
GSK Investigational Site
Portland, Oregon, 97219
GSK Investigational Site
Providence, Rhode Island, 02903
GSK Investigational Site
Reading, Pennsylvania, 19601
GSK Investigational Site
San Francisco, California, 94115-1931
GSK Investigational Site
Seattle, Washington, 98104
GSK Investigational Site
Stony Brook, New York, 11794
GSK Investigational Site
Tacoma, Washington, 98405
GSK Investigational Site
Tampa, Florida, 33602
GSK Investigational Site
Tyler, Texas, 75708
GSK Investigational Site
Vero Beach, Florida, 32960
GSK Investigational Site
Washington D.C., District of Columbia, 20007-2113
GSK Investigational Site
Washington D.C., District of Columbia, 20009
GSK Investigational Site
Washington D.C., District of Columbia, 20036
GSK Investigational Site
Wichita, Kansas, 67214
About this study
Official title: A Phase III, Randomized, Open-label, Multicenter Study of the Safety and Efficacy of Efavirenz Versus Tenofovir When Administered in Combination With the Abacavir/Lamivudine Fixed-dose Combination Tablet as a Once-daily Regimen in Antiretroviral-naive HIV-1 Infected Subjects.
This is a 48-week study to evaluate the safety and efficacy of a new tablet formulation containing two FDA-approved drugs in HIV-infected patients who have not received prior therapy. This tablet will be taken with one of two FDA-approved drugs as a once-daily regimen. Study physicians will evaluate subjects to determine if they have certain medical conditions, laboratory test values, medication use, or drug allergies that would exclude them from the study.
- Conditions
- HIV Infection
- Being tested
- efavirenz, tenofovir, abacavir/lamivudine
- Keywords
- HIV-1 Efavirenz Tenofovir
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
efavirenzDrug
tenofovirDrug
abacavir/lamivudineDrug
Also called efavirenz, tenofovir
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral load response at 48 weeks
Measured: 48 weeks
Secondary outcomes (1)
Safety and tolerability Viral load response at 24 weeks Change in T-cell count Resistance Pharmacokinetics
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2003 (estimated)
- Study startFeb 2003
- Primary completionOct 2004
- Study completionOct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- 345 participants
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trials, MD, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00053638
- Sponsor's protocol ID
- ESS30009
- Status last verified
- Oct 2010
- First submitted
- 4 Feb 2003
- Last updated
- 4 Oct 2010
- Results posted
- No
Publications
Underwood MR, Ross LL, Irlbeck DM, Gerondelis P, Rouse E, St Clair MH, Trinh L, Parkin N, Lanier E. Sensitivity of phenotypic susceptibility analyses for nonthymidine nucleoside analogues conferred by K65R or M184V in mixtures with wild-type HIV-1. J Infect Dis. 2009 Jan 1;199(1):84-8. doi: 10.1086/595296.
PubMed 19032103
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Open-label, Multicenter Study of the Safety and Efficacy of Efavirenz Versus Tenofovir When Administered in Combination With the Abacavir/Lamivudine Fixed-dose Combination Tablet as a Once-daily Regimen in Antiretroviral-naive HIV-1 Infected Subjects.
- ClinicalTrials.gov ID
- NCT00053638
- Acronym / sponsor ID
- ESS30009
- Conditions
- HIV Infection
- Keywords
- HIV-1 Efavirenz Tenofovir
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 345 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Feb 2003
- Primary completion
- Oct 2004 (actual)
- Study completion
- Oct 2004 (actual)
- First posted
- 5 Feb 2003 (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 is a 48-week study to evaluate the safety and efficacy of a new tablet formulation containing two FDA-approved drugs in HIV-infected patients who have not received prior therapy. This tablet will be taken with one of two FDA-approved drugs as a once-daily regimen. Study physicians will evaluate subjects to determine if they have certain medical conditions, laboratory test values, medication use, or drug allergies that would exclude them from the 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 (6 listed)
- Participants must be able to provide informed consent.
- Have documented HIV-1 infection.
- Have not received more than 14 days of prior treatment with antiretroviral drugs.
- Meet laboratory test criteria.
- Women of childbearing potential must abstain from sexual intercourse or use acceptable contraception.
Key exclusion criteria (2 listed)
- Enrolled in other HIV treatment studies.
- Pregnant or breastfeeding.
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 |
|---|---|---|
| efavirenz | Drug | – |
| tenofovir | Drug | – |
| abacavir/lamivudineAlso: efavirenz, tenofovir | Drug | – |
Primary outcome
Viral load response at 48 weeks
Time frame: 48 weeks
1 secondary outcome
Safety and tolerability Viral load response at 24 weeks Change in T-cell count Resistance Pharmacokinetics
Time frame: 48 weeks
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 4 Oct 2010.
- Derived from this study: PubMed 19032103Underwood MR, Ross LL, Irlbeck DM, Gerondelis P, Rouse E, St Clair MH, Trinh L, Parkin N, Lanier E. Sensitivity of phenotypic susceptibility analyses for nonthymidine nucleoside analogues conferred by K65R or M184V in mixtures with wild-type HIV-1. J Infect Dis. 2009 Jan 1;199(1):84-8. doi: 10.1086/595296.
Related trials for HIV Infection
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.
GSK Clinical Trials, MD study director
GlaxoSmithKline
58 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 efavirenz, tenofovir and abacavir/lamivudine in people with HIV Infection, run by GlaxoSmithKline at 58 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 6 inclusion and 2 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 4 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 58 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?
Viral load response at 48 weeks (time frame: 48 weeks). 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 NCT00053638, which also lists 1 linked publication.
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 4 Oct 2010.