HIV InfectionsPhase 4NCT00011895
Safety and Effectiveness of TRIZIVIR (Abacavir/Lamivudine/Zidovudine) With Efavirenz in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
A Phase 4 study testing Abacavir sulfate, Lamivudine and Zidovudine and Efavirenz in people with HIV Infections, run by GlaxoSmithKline at 42 sites in United States.
Trial summary
The purpose of this study is to determine the effect of treatment with Trizivir (TZV) plus efavirenz (EFV) or TZV alone on viral load (level of HIV in the blood). Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Abacavir sulfate, Lamivudine and Zidovudine and Efavirenz
- How many people
- 400 participants
- Where
- 42 sitesUnited States
- Study dates
- Feb 2001to not given
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients may be eligible for this study if they:
- Are at least 13 years old.
- Are HIV-positive.
- Have a viral load of at least 5,000 copies/ml.
- Agree to use adequate and reliable methods of birth control. Note: Hormonal birth control is not considered adequate.
- Provide written consent of a parent or guardian, if under 18 years of age.
Who cannot join
- Patients will not be eligible for this study if they:
- Have taken nonnucleoside reverse transcriptase inhibitors.
- Have taken other anti-HIV drugs for 2 weeks or more.
- Have an opportunistic (AIDS-related) infection.
- Are pregnant or breast-feeding.
- Have had hepatitis within the past 6 months.
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- Are allergic to the study drugs or their ingredients.
- Have a mental, physical, or substance abuse disorder.
- Have a serious medical condition, such as diabetes, congestive heart failure, or other heart disease.
- Have a gastrointestinal disorder that affects drug absorption or makes it difficult to take medication by mouth.
- Have received within 4 weeks before study entry, or may require during the study period, radiation therapy, chemotherapy, or drugs that affect the immune system (such as steroid drugs, interleukins, vaccines, or interferons).
- Have received an HIV vaccine within 3 months before study entry, or are scheduled to receive one during the study period.
- Require foscarnet or other drugs that are shown to be effective against HIV.
- Are taking astemizole, cisapride, midazolam, triazolam, or ergot derivatives.
- Are taking experimental drugs.
- Are unlikely to complete the study or take the drugs.
Trial locations and contacts
42 sites in 1 country.
42 sites in 1 country
United States42 sites
Summa Health System
Akron, Ohio, 44304
Infectious Disease Consultants
Altamonte Springs, Florida, 32701
Infectious Disease Physicians Inc
Annandale, Virginia, 22003
Dr Paul Benson
Berkley, Michigan, 48072
Boston Med Ctr
Boston, Massachusetts, 02118
Beacon Clinic / Boulder Community Hosp
Boulder, Colorado, 80304
SUNY / Health Sciences Ctr at Brooklyn
Brooklyn, New York, 11203
ID Consultants
Charlotte, North Carolina, 28203
Cook County Gen Hosp / Division of Infect Diseases
Chicago, Illinois, 60612
Northstar Med Clinic
Chicago, Illinois, 60657
Infectious Disease Specialists of Atlanta
Decatur, Georgia, 30033
Texas Tech Health Sciences Ctr
El Paso, Texas, 79905
Infectious Disease Consultants
Fairfax, Virginia, 22030
North Broward Hosp District / HIV Clinical Research
Fort Lauderdale, Florida, 33311
AIDS Outreach Center
Fort Worth, Texas, 76104
Metroplex Infectious Disease
Fort Worth, Texas, 76104
Tarrant County Infectious Diseases Associates
Fort Worth, Texas, 76104
Orange County Ctr for Special Immunology
Fountain Valley, California, 92708
East Carolina Univ School of Medicine
Greenville, North Carolina, 27858
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Therapeutic Concepts
Houston, Texas, 77004
Diversified Med Practices, PA
Houston, Texas, 77027
Infectious Diseases Associates of Houston
Houston, Texas, 77030
CRC of Mississippi
Jackson, Mississippi, 39202
Univ of Tennessee Med Ctr at Knoxville
Knoxville, Tennessee, 37920
Wellness Ctr / Las Vegas
Las Vegas, Nevada, 89102
Health for Life Clinic
Little Rock, Arkansas, 72205
University of Louisville / ID Division
Louisville, Kentucky, 40202
Univ of Miami / Jackson Memorial Hosp
Miami, Florida, 33136
SBMA Research
Miami Beach, Florida, 33140
Hennepin County Med Ctr
Minneapolis, Minnesota, 55415
HIV Outpatient Clinics / LA State Univ Med Ctr
New Orleans, Louisiana, 70112
Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ
New York, New York, 10021
NJCRI
Newark, New Jersey, 07103
Univ of Oklahoma Infectious Disease Institute
Oklahoma City, Oklahoma, 73117
Phoenix Body Positive
Phoenix, Arizona, 85006
Regions Hosp / HIV/AIDS Program
Saint Paul, Minnesota, 55101
Pacific Horizons Med Group
San Francisco, California, 94115
Swedish Med Ctr
Seattle, Washington, 98122
Associates in Med and Mental Health
Tulsa, Oklahoma, 74114
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007
Dupont Circle Physicians Group
Washington D.C., District of Columbia, 200091104
About this study
Official title: A Phase IV Multicenter Study of the Efficacy and Safety of 48-Week Induction Treatment With TRIZIVIR (Abacavir 300 Mg/Lamivudine 150 Mg/Zidovudine 300 Mg Combination Tablet BID) With Efavirenz (600 Mg QD) Followed by 48-Week Randomized, Open-Label, Maintenance Treatment With TRIZIVIR With or Without Efavirenz in HIV-1 Infected Antiretroviral Therapy Naive Subjects
The purpose of this study is to determine the effect of treatment with Trizivir (TZV) plus efavirenz (EFV) or TZV alone on viral load (level of HIV in the blood).
Read the detailed description
Patients receive TZV plus EFV in the 48-week Induction Phase. Eligible patients, defined as those with plasma HIV-1 RNA under 50 copies/ml, participate in the 48-week Maintenance Phase. Patients are randomized equally to receive either TZV plus EFV or TZV alone.
An immunology substudy will be conducted, including approximately the first 100 patients enrolled who agree to participate.
- Conditions
- HIV Infections
- Being tested
- Abacavir sulfate, Lamivudine and Zidovudine, Efavirenz
- Keywords
- HIV-1, Drug Therapy, Combination, Zidovudine, Lamivudine, Drug Combinations, RNA, Viral, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load, abacavir, efavirenz
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abacavir sulfate, Lamivudine and ZidovudineDrug
EfavirenzDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study startFeb 2001
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 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 4
- Primary purpose
- Treatment
- Enrolment
- 400 participants
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00011895
- Sponsor's protocol ID
- 308B
- Other IDs
- ESS40013
- Status last verified
- Mar 2002
- First submitted
- 2 Mar 2001
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV Multicenter Study of the Efficacy and Safety of 48-Week Induction Treatment With TRIZIVIR (Abacavir 300 Mg/Lamivudine 150 Mg/Zidovudine 300 Mg Combination Tablet BID) With Efavirenz (600 Mg QD) Followed by 48-Week Randomized, Open-Label, Maintenance Treatment With TRIZIVIR With or Without Efavirenz in HIV-1 Infected Antiretroviral Therapy Naive Subjects
- ClinicalTrials.gov ID
- NCT00011895
- Acronym / sponsor ID
- 308B
- Conditions
- HIV Infections
- Keywords
- HIV-1, Drug Therapy, Combination, Zidovudine, Lamivudine, Drug Combinations, RNA, Viral, Reverse Transcriptase Inhibitors, Anti-HIV Agents
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Feb 2001
- First posted
- 31 Aug 2001 (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 determine the effect of treatment with Trizivir (TZV) plus efavirenz (EFV) or TZV alone on viral load (level of HIV in the blood).
Detailed description
Patients receive TZV plus EFV in the 48-week Induction Phase. Eligible patients, defined as those with plasma HIV-1 RNA under 50 copies/ml, participate in the 48-week Maintenance Phase. Patients are randomized equally to receive either TZV plus EFV or TZV alone.
An immunology substudy will be conducted, including approximately the first 100 patients enrolled who agree to participate.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Are at least 13 years old.
- Are HIV-positive.
- Have a viral load of at least 5,000 copies/ml.
- Agree to use adequate and reliable methods of birth control. Note: Hormonal birth control is not considered adequate.
- Provide written consent of a parent or guardian, if under 18 years of age.
Key exclusion criteria (16 listed)
- Have taken nonnucleoside reverse transcriptase inhibitors.
- Have taken other anti-HIV drugs for 2 weeks or more.
- Have an opportunistic (AIDS-related) infection.
- Are pregnant or breast-feeding.
- Have had hepatitis within the past 6 months.
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 |
|---|---|---|
| Abacavir sulfate, Lamivudine and Zidovudine | Drug | – |
| Efavirenz | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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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.
42 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Abacavir sulfate, Lamivudine and Zidovudine and Efavirenz in people with HIV Infections, run by GlaxoSmithKline at 42 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 16 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: status not confirmed, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 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 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?
Results are not available in the source record.
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.
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 24 Jun 2005.