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UNKNOWNPHASE4

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

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

NCT00011895•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

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).

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

Age

13 - No limit years

Sex

ALL

Healthy Volunteers

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.
+6 more criteria

Locations (42)

Phoenix Body Positive

Phoenix, Arizona, United States

Health for Life Clinic

Little Rock, Arkansas, United States

Orange County Ctr for Special Immunology

Fountain Valley, California, United States

Pacific Horizons Med Group

San Francisco, California, United States

Beacon Clinic / Boulder Community Hosp

Boulder, Colorado, United States

Georgetown Univ Med Ctr

Washington D.C., District of Columbia, United States

Dupont Circle Physicians Group

Washington D.C., District of Columbia, United States

Infectious Disease Consultants

Altamonte Springs, Florida, United States

North Broward Hosp District / HIV Clinical Research

Fort Lauderdale, Florida, United States

Univ of Miami / Jackson Memorial Hosp

Miami, Florida, United States

Key Dates

Start Date

February 1, 2001

Last Updated

June 24, 2005

Enrollment

400

Estimated participants

Conditions

HIV Infections

Interventions

Abacavir sulfate, Lamivudine and Zidovudine

DRUG

Efavirenz

DRUG

Skeletal Muscle Energetics and Fatiguability in Older Individuals

NCT04142047

HIVHIV Infections

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RECRUITINGPHASE3

A Study to Evaluate the Effectiveness of Long-acting (LA) Cabotegravir (CAB) + Rilpivirine (RPV) LA When Given to Participants With Detectable HIV-1

NCT06694805

HIV Infections

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 24, 2005Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Skeletal Muscle Energetics and Fatiguability in Older Individuals

A Study to Evaluate the Effectiveness of Long-acting (LA) Cabotegravir (CAB) + Rilpivirine (RPV) LA When Given to Participants With Detectable HIV-1

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