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

This study is ongoing, but not recruiting participants.

First Received: March 2, 2001 Last Updated: June 23, 2005 History of Changes

Sponsored by:	GlaxoSmithKline
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00011895

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 IV

MedlinePlus related topics: AIDS AIDS Medicines

Drug Information available for: Zidovudine Lamivudine Abacavir Efavirenz Abacavir sulfate Trizivir

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Safety 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

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

Ages Eligible for Study:	13 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00011895

Show 42 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

More Information

No publications provided

Study ID Numbers:	308B, ESS40013
Study First Received:	March 2, 2001
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00011895 History of Changes
Health Authority:	United States: Food and Drug Administration

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

Study placed in the following topic categories:

Antimetabolites
Efavirenz
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Acquired Immunodeficiency Syndrome
Zidovudine
Lamivudine
Antiviral Agents

Immunologic Deficiency Syndromes
Reverse Transcriptase Inhibitors
Virus Diseases
Anti-Retroviral Agents
HIV Infections
Sexually Transmitted Diseases
Abacavir
Retroviridae Infections

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Zidovudine
Lamivudine
Infection
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Abacavir
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors

Efavirenz
RNA Virus Infections
Anti-HIV Agents
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on May 06, 2009