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Safety and Effectiveness of TRIZIVIR (Abacavir/Lamivudine/Zidovudine) With Efavirenz in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs

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 March 2002 by NIH AIDS Clinical Trials Information Service.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00011895
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
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.
Information provided by:
NIH AIDS Clinical Trials Information Service
  Purpose
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).

Condition Intervention Phase
HIV Infections Drug: Abacavir sulfate, Lamivudine and Zidovudine Drug: Efavirenz Phase 4

Study Type: Interventional
Study Design: Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 400
Study Start Date: February 2001
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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   13 Years and older   (Child, 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 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.

Exclusion Criteria

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.
  • 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.
  Contacts and Locations
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): NCT00011895


  Show 42 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
  More Information

ClinicalTrials.gov Identifier: NCT00011895     History of Changes
Other Study ID Numbers: 308B
ESS40013
First Submitted: March 2, 2001
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
Last Verified: March 2002

Keywords provided by NIH AIDS Clinical Trials Information Service:
HIV-1
Drug Therapy, Combination
Zidovudine
Lamivudine
Drug Combinations
RNA, Viral
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Viral Load
abacavir
efavirenz

Additional relevant MeSH terms:
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
Efavirenz
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
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers