HIV InfectionsPhase 3NCT00004981
Safety and Effectiveness of Three Anti-HIV Drugs Combined in One Pill (Trizivir)
A Phase 3 study testing Abacavir sulfate, Lamivudine and Zidovudine, Lamivudine/Zidovudine and Abacavir sulfate in people with HIV Infections, run by Glaxo Wellcome at 25 sites in United States.
Trial summary
The purpose of this study is to look at the safety and effectiveness of a pill called Trizivir that is a combination of three anti-HIV drugs (zidovudine, lamivudine, and abacavir). Zidovudine and lamivudine are often given combined in one pill (Combivir). 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?
- Abacavir sulfate, Lamivudine and Zidovudine, Lamivudine/Zidovudine and Abacavir sulfate
- How many people
- 230 participants
- Where
- 25 sitesUnited States
- Study dates
- Start not givento not given
- 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
- Patients may be eligible for this study if they:
- Are at least 18 years old.
- Are HIV-positive.
- Are currently receiving one of the following anti-HIV drug combinations: Combivir plus abacavir, Combivir plus abacavir plus a protease inhibitor, or Combivir plus abacavir plus a non-nucleoside reverse transcriptase inhibitor (NNRTI). Patients must have been taking this drug combination for at least the past 16 weeks. This also must be the first anti-HIV drug combination the patient has received.
- Have a viral load (level of HIV in the blood) less than or equal to 400 copies/ml.
- Have CD4+ cell count greater than 200 cells/mm3.
- Agree to use effective methods of birth control.
Who cannot join
- Patients will not be eligible for this study if they:
- Have been diagnosed with AIDS.
- Have a gastrointestinal disorder that makes it difficult for patients to absorb food or to take medications by mouth.
- Have hepatitis.
- Have a serious medical condition, such as diabetes, congestive heart failure, or other heart disease.
- Are allergic to any of the study drugs.
Show all 11Show fewer
- Abuse alcohol or drugs.
- Will not be available for the entire 24-week study period.
- Are pregnant or breast-feeding.
- Have taken or will need to take certain medications, including radiation therapy, chemotherapy, drugs that affect the immune system (such as interleukin), an HIV vaccine, foscarnet, and hydroxyurea.
- Are enrolled in another experimental drug study.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Lehigh Valley Hosp
Allentown, Pennsylvania, 18105
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
New England Med Ctr
Boston, Massachusetts, 02111
Addiction Research and Treatment Corp
Brooklyn, New York, 11201
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
Burnside Clinic
Columbia, South Carolina, 29206
Nicholas Bellos
Dallas, Texas, 75246
Univ of Texas Med Branch
Galveston, Texas, 77555
Therapeutic Concepts
Houston, Texas, 77004
Research Med Ctr
Kansas City, Missouri, 64111
AIDS Healthcare Foundation
Los Angeles, California, 900276069
Tower Infectious Disease Med Ctr
Los Angeles, California, 90048
Univ of Tennessee
Memphis, Tennessee, 38163
Univ of Miami School of Medicine
Miami, Florida, 33136
Specialty Med Care Ctrs of South Florida Inc
Miami, Florida, 33142
Nashville Health Management Foundation / Vanderbilt Univ
Nashville, Tennessee, 37203
Saint Vincent's Hosp and Med Ctr
New York, New York, 10011
St Luke Roosevelt Hosp
New York, New York, 10011
Robert Scott MD
Oakland, California, 94609
Hahnemann Univ Hosp
Philadelphia, Pennsylvania, 191021192
Anderson Clinical Research
Pittsburgh, Pennsylvania, 15213
St Lukes Medical Group
San Diego, California, 92101
Saint Josephs Comprehensive Research Institute
Tampa, Florida, 33607
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007
Whitman Walker Clinic
Washington D.C., District of Columbia, 20009
About this study
Official title: A Phase IIIB Randomized, Multicenter Study of the Efficacy and Safety of Combivir 1 Tablet Po Bid Plus Ziagen 300mg Po Bid Versus an Abacavir 300mg/Lamivudine 150mg/Zidovudine 300mg Combination Tablet Po Bid, Administered for 24 Weeks in Subjects With HIV-1 Infection
The purpose of this study is to look at the safety and effectiveness of a pill called Trizivir that is a combination of three anti-HIV drugs (zidovudine, lamivudine, and abacavir). Zidovudine and lamivudine are often given combined in one pill (Combivir). In this study, Trizivir will be compared to Combivir plus abacavir.
Read the detailed description
Patients are randomized to receive either the triple combination tablet (Trizivir) or to receive Combivir plus abacavir as a separate tablet. Patients take their study medications for 24 weeks.
- Conditions
- HIV Infections
- Being tested
- Abacavir sulfate, Lamivudine and Zidovudine, Lamivudine/Zidovudine, Abacavir sulfate
- Keywords
- Drug Therapy, Combination, Zidovudine, Drug Administration Schedule, Lamivudine, RNA, Viral, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load, Combivir, abacavir
- 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
Lamivudine/ZidovudineDrug
Abacavir sulfateDrug
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)
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.
- 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
- Enrolment
- 230 participants
Sponsor and investigators
- Lead sponsor
- Glaxo Wellcome
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004981
- Sponsor's protocol ID
- 308A
- Other IDs
- ESS40005
- Status last verified
- Jun 2001
- First submitted
- 13 Mar 2000
- 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 IIIB Randomized, Multicenter Study of the Efficacy and Safety of Combivir 1 Tablet Po Bid Plus Ziagen 300mg Po Bid Versus an Abacavir 300mg/Lamivudine 150mg/Zidovudine 300mg Combination Tablet Po Bid, Administered for 24 Weeks in Subjects With HIV-1 Infection
- ClinicalTrials.gov ID
- NCT00004981
- Acronym / sponsor ID
- 308A
- Conditions
- HIV Infections
- Keywords
- Drug Therapy, Combination, Zidovudine, Drug Administration Schedule, Lamivudine, RNA, Viral, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 230 participants
- Lead sponsor
- Glaxo WellcomeIndustry (pharma, biotech, devices)
- 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 look at the safety and effectiveness of a pill called Trizivir that is a combination of three anti-HIV drugs (zidovudine, lamivudine, and abacavir). Zidovudine and lamivudine are often given combined in one pill (Combivir). In this study, Trizivir will be compared to Combivir plus abacavir.
Detailed description
Patients are randomized to receive either the triple combination tablet (Trizivir) or to receive Combivir plus abacavir as a separate tablet. Patients take their study medications for 24 weeks.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Are at least 18 years old.
- Are HIV-positive.
- Are currently receiving one of the following anti-HIV drug combinations: Combivir plus abacavir, Combivir plus abacavir plus a protease inhibitor, or Combivir plus abacavir plus a non-nucleoside reverse transcriptase inhibitor (NNRTI). Patients must have been taking this drug combination for at least the past 16 weeks. This also must be the first anti-HIV drug combination the patient has received.
- Have a viral load (level of HIV in the blood) less than or equal to 400 copies/ml.
- Have CD4+ cell count greater than 200 cells/mm3.
Key exclusion criteria (11 listed)
- Have been diagnosed with AIDS.
- Have a gastrointestinal disorder that makes it difficult for patients to absorb food or to take medications by mouth.
- Have hepatitis.
- Have a serious medical condition, such as diabetes, congestive heart failure, or other heart disease.
- Are allergic to any of the study drugs.
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 | – |
| Lamivudine/Zidovudine | Drug | – |
| Abacavir sulfate | 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.
25 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 Abacavir sulfate, Lamivudine and Zidovudine, Lamivudine/Zidovudine and Abacavir sulfate in people with HIV Infections, run by Glaxo Wellcome at 25 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 7 inclusion and 11 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 25 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?
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.