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NCT00050895

Comparing the Safety, Effectiveness, and Tolerability of Three Anti-HIV Drug Regimens for Treatment-Naive Patients

Last Updated: 2021-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

775 participants

Study Classification

INTERVENTIONAL

Study Completion Date

2006-03-31

Brief Summary

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With new strategies and drugs available, many different regimens exist for the treatment of HIV. The purpose of this study is to compare three different anti-HIV drug regimens as first-time treatments for HIV infection.

Detailed Description

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Numerous treatment options are available to HIV infected patients who are antiretroviral (ARV) therapy naive, but an optimal regimen has not yet been established. This study will compare a nonnucleoside reverse transcriptase inhibitor (NNRTI)-based regimen, a ritonavir (RTV)-enhanced protease inhibitor (PI)-based regimen, and a nucleoside reverse transcriptase inhibitor (NRTI)-sparing regimen for the initial treatment of HIV infection.

Patients will be randomly assigned to one of three study arms. In Arm A, patients will receive lopinavir/ritonavir (LPV/r) twice daily and efavirenz (EFV) once daily before bed. Arm B patients will receive LPV/r twice daily, lamivudine (3TC) once daily, plus either stavudine extended release (d4T XR) once daily, zidovudine (ZDV) twice daily, or tenofovir disoproxil fumarate (TDF) once daily. Patients in Arm C will receive EFV once daily before bed and 3TC plus either d4T XR once daily before bed, ZDV twice daily, or TDF once daily before bed.

Study visits will occur every 4 weeks until Week 24, then every 8 weeks thereafter for a maximum of 96 weeks. Blood will be drawn at every visit and a urine sample will be collected every 8 weeks. Body measurements will be taken at Weeks 24, 48, 72, and 96. Whole body dual-energy x-ray absorptiometry (DEXA) scans will be done at Weeks 48 and 96. Patients must fast before study visits at Weeks 12, 24, 48, 72, and 96. Women in the study will have gynecological assessments every 24 weeks.

Conditions

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HIV Infections

Keywords

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Reverse Transcriptase Inhibitors HIV Protease Inhibitors Drug Therapy, Combination Delayed Action Preparations Treatment Naive HIV-1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Lopinavir/ritonavir

Intervention Type DRUG

Efavirenz

Intervention Type DRUG

Stavudine

Intervention Type DRUG

Zidovudine

Intervention Type DRUG

Lamivudine

Intervention Type DRUG

Tenofovir disoproxil fumarate

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* HIV infected
* HIV viral load of 2000 copies/ml or greater within 60 days prior to study entry
* Willing to use acceptable means of contraception
* d4T XR, TDF, or ZDV chosen as part of an initial regimen prior to randomization to a study arm
* Coenrolled in ACTG A5152s

Exclusion Criteria

* On ARV therapy for 7 days or more any time prior to study entry
* NNRTIs or 3TC at any time prior to study entry
* Current peripheral neuropathy of Grade 2 or higher
* Pregnancy or breastfeeding
* Immunomodulators, vaccines, or investigational therapies within 30 days of study entry. Patients taking a stable or tapering dose of prednisone at less than 10 mg are not excluded.
* Human growth hormone within 30 days prior to study entry
* Initiation of testosterone or anabolic steroids within 30 days prior to study entry
* Certain other medications within 30 days of study entry
* Hypersensitivity to components of the study drug formulations
* Drug or alcohol use or dependence that would interfere with adherence to study requirements
* Acute therapy for serious medical illnesses requiring systemic treatment and/or hospitalization within 14 days prior to study entry
* Recent infection with drug-resistant HIV

Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sharon Riddler, MD

Role: STUDY_CHAIR

University of Pittsburgh

Richard Haubrich, MD

Role: STUDY_CHAIR

University of California, San Diego, Division of Infectious Diseases

Locations

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Alabama Therapeutics CRS

Birmingham, Alabama, United States

Site Status

USC CRS

Los Angeles, California, United States

Site Status

UCLA CARE Center CRS

Los Angeles, California, United States

Site Status

Stanford CRS

Palo Alto, California, United States

Site Status

UC Davis Medical Center

Sacramento, California, United States

Site Status

Univ. of California Davis Med. Ctr., ACTU

Sacramento, California, United States

Site Status

Ucsd, Avrc Crs

San Diego, California, United States

Site Status

Ucsf Aids Crs

San Francisco, California, United States

Site Status

Santa Clara Valley Med. Ctr.

San Jose, California, United States

Site Status

San Mateo County AIDS Program

San Mateo, California, United States

Site Status

Harbor-UCLA Med. Ctr. CRS

Torrance, California, United States

Site Status

University of Colorado Hospital CRS

Aurora, Colorado, United States

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Georgetown University CRS (GU CRS)

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

Site Status

Univ. of Miami AIDS CRS

Miami, Florida, United States

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The Ponce de Leon Ctr. CRS

Atlanta, Georgia, United States

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Univ. of Hawaii at Manoa, Leahi Hosp.

Honolulu, Hawaii, United States

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Northwestern University CRS

Chicago, Illinois, United States

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Rush Univ. Med. Ctr. ACTG CRS

Chicago, Illinois, United States

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Cook County Hosp. CORE Ctr.

Chicago, Illinois, United States

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Methodist Hosp. of Indiana

Indianapolis, Indiana, United States

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Indiana Univ. School of Medicine, Infectious Disease Research Clinic

Indianapolis, Indiana, United States

Site Status

Indiana Univ. School of Medicine, Wishard Memorial

Indianapolis, Indiana, United States

Site Status

Univ. of Iowa Healthcare, Div. of Infectious Diseases

Iowa City, Iowa, United States

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IHV Baltimore Treatment CRS

Baltimore, Maryland, United States

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Johns Hopkins Adult AIDS CRS

Baltimore, Maryland, United States

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Massachusetts General Hospital ACTG CRS

Boston, Massachusetts, United States

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Bmc Actg Crs

Boston, Massachusetts, United States

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Beth Israel Deaconess Med. Ctr., ACTG CRS

Boston, Massachusetts, United States

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Brigham and Women's Hosp. ACTG CRS

Boston, Massachusetts, United States

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SSTAR, Family Healthcare Ctr.

Fall River, Massachusetts, United States

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University of Minnesota, ACTU

Minneapolis, Minnesota, United States

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St. Louis ConnectCare, Infectious Diseases Clinic

St Louis, Missouri, United States

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Washington U CRS

St Louis, Missouri, United States

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Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.

Omaha, Nebraska, United States

Site Status