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Safety and Effectiveness of Three Anti-HIV Drugs Combined in One Pill (Trizivir)
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2001 by NIH AIDS Clinical Trials Information Service.
Recruitment status was: Active, not recruiting
Recruitment status was: Active, not recruiting
Sponsor:
Glaxo Wellcome
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00004981
First received: March 13, 2000
Last updated: June 23, 2005
Last verified: June 2001
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| HIV Infections | Drug: Abacavir sulfate, Lamivudine and Zidovudine Drug: Lamivudine/Zidovudine Drug: Abacavir sulfate | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by NIH AIDS Clinical Trials Information Service:
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria
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.
Exclusion Criteria
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.
- 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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004981
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004981
Locations
| United States, California | |
| AIDS Healthcare Foundation | |
| Los Angeles, California, United States, 900276069 | |
| Tower Infectious Disease Med Ctr | |
| Los Angeles, California, United States, 90048 | |
| Robert Scott MD | |
| Oakland, California, United States, 94609 | |
| St Lukes Medical Group | |
| San Diego, California, United States, 92101 | |
| United States, District of Columbia | |
| Georgetown Univ Med Ctr | |
| Washington, District of Columbia, United States, 20007 | |
| Whitman Walker Clinic | |
| Washington, District of Columbia, United States, 20009 | |
| United States, Florida | |
| Univ of Miami School of Medicine | |
| Miami, Florida, United States, 33136 | |
| Specialty Med Care Ctrs of South Florida Inc | |
| Miami, Florida, United States, 33142 | |
| Saint Josephs Comprehensive Research Institute | |
| Tampa, Florida, United States, 33607 | |
| United States, Georgia | |
| AIDS Research Consortium of Atlanta | |
| Atlanta, Georgia, United States, 30308 | |
| United States, Illinois | |
| Rush Presbyterian - Saint Luke's Med Ctr | |
| Chicago, Illinois, United States, 60612 | |
| United States, Massachusetts | |
| New England Med Ctr | |
| Boston, Massachusetts, United States, 02111 | |
| United States, Missouri | |
| Research Med Ctr | |
| Kansas City, Missouri, United States, 64111 | |
| United States, New York | |
| Addiction Research and Treatment Corp | |
| Brooklyn, New York, United States, 11201 | |
| Saint Vincent's Hosp and Med Ctr | |
| New York, New York, United States, 10011 | |
| St Luke Roosevelt Hosp | |
| New York, New York, United States, 10011 | |
| United States, Pennsylvania | |
| Lehigh Valley Hosp | |
| Allentown, Pennsylvania, United States, 18105 | |
| Hahnemann Univ Hosp | |
| Philadelphia, Pennsylvania, United States, 191021192 | |
| Anderson Clinical Research | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, South Carolina | |
| Burnside Clinic | |
| Columbia, South Carolina, United States, 29206 | |
| United States, Tennessee | |
| Univ of Tennessee | |
| Memphis, Tennessee, United States, 38163 | |
| Nashville Health Management Foundation / Vanderbilt Univ | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| Nicholas Bellos | |
| Dallas, Texas, United States, 75246 | |
| Univ of Texas Med Branch | |
| Galveston, Texas, United States, 77555 | |
| Therapeutic Concepts | |
| Houston, Texas, United States, 77004 | |
Sponsors and Collaborators
Glaxo Wellcome
More Information
| ClinicalTrials.gov Identifier: | NCT00004981 History of Changes |
| Other Study ID Numbers: |
308A ESS40005 |
| Study First Received: | March 13, 2000 |
| Last Updated: | June 23, 2005 |
Keywords provided by NIH AIDS Clinical Trials Information Service:
|
Drug Therapy, Combination Zidovudine Drug Administration Schedule Lamivudine RNA, Viral |
Reverse Transcriptase Inhibitors Anti-HIV Agents Viral Load Combivir abacavir |
Additional relevant MeSH terms:
|
Infection HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Lamivudine Zidovudine |
Abacavir Dideoxynucleosides Lamivudine, zidovudine drug combination Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Anti-HIV Agents Antimetabolites |
ClinicalTrials.gov processed this record on July 25, 2017