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Safety and Effectiveness of Three Anti-HIV Drugs Combined in One Pill (Trizivir)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00004981
Recruitment Status : Unknown
Verified June 2001 by NIH AIDS Clinical Trials Information Service.
Recruitment status was:  Active, not recruiting
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service

Study Description
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Brief 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). In this study, Trizivir will be compared to Combivir plus abacavir.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Abacavir sulfate, Lamivudine and Zidovudine Drug: Lamivudine/Zidovudine Drug: Abacavir sulfate Phase 3

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
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Study Type : Interventional  (Clinical Trial)
Enrollment : 230 participants
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 the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004981


Locations
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Sponsors and Collaborators
Glaxo Wellcome
More Information
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ClinicalTrials.gov Identifier: NCT00004981    
Other Study ID Numbers: 308A
ESS40005
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: June 2001
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:
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Infection
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