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A Comparison of Three Anti-HIV Drug Combinations in HIV-Infected Patients

Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections

Intervention: Lamivudine/Zidovudine (Drug); Abacavir sulfate (Drug); Nelfinavir mesylate (Drug); Lamivudine (Drug); Stavudine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Glaxo Wellcome

Summary

The purpose of this study is to look at the effects of different anti-HIV drug combinations on body fat changes in HIV-positive patients who have never received anti-HIV therapy before.

Clinical Details

Official title: A 96-Week, Randomized, Open-Label, Multicenter Trial to Evaluate the Safety and Tolerability of the Antiretroviral Activity of Stavudine (40mg BID) Plus Lamivudine (150mg BID) Plus Nelfinavir (1250mg BID) Versus Abacavir (300mg BID) Plus Combivir (3TC 150mg/ZDV 300mg BID) Versus Combivir (3TC 150mg/ZDV 300mg BID) Plus Nelfinavir (1250mg BID) in HIV-1 Infected Subjects

Study design: Treatment, Parallel Assignment, Safety Study

Detailed description: Patients are randomized to receive stavudine plus lamivudine plus nelfinavir, Combivir (zidovudine plus lamivudine) plus nelfinavir, or Combivir plus abacavir. Patients are stratified into 2 groups based on their screening plasma HIV-1 RNA: (1) greater than 1,000 up to 100,000 copies/ml or (2) greater than 100,000 up to 200,000 copies/ml. Measurements and evaluations for assessment of body fat composition, virologic and immunologic outcomes, markers of alterations in carbohydrate and lipid metabolism, and safety are performed at Baseline, Weeks 4, 8, 16, 24, and every 12 weeks thereafter until Week 96 or withdrawal. In addition, health-related quality of life and health care resource utilization data are collected at specified treatment visits.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria

Patients may be eligible for this study if they:

- Are at least 18 years old.

- Are HIV-positive.

- Have a CD4 count greater than 50 cells/mm3.

- Have a viral load greater than 1,000 copies/ml but less than 200,000 copies/ml.

- Have never received anti-HIV medications before. (However, less than 1 week of therapy

with lamivudine or a protease inhibitor and less than 4 weeks of therapy with other nucleoside reverse transcriptase inhibitors [NRTIs] is allowed. No therapy with nonnucleoside reverse transcriptase inhibitors [NNRTIs] is allowed.)

- Cannot bear children or agree to use effective methods of birth control during the

study. Hormonal methods of birth control (such as birth control pills) are not considered effective for this study.

Exclusion Criteria

Patients will not be eligible for this study if they:

- Have an active AIDS-defining opportunistic infection or disease that, in the doctor's

opinion, would make them unable to participate.

- Are unable, in the opinion of the doctor, to follow the dosing schedule and follow-up

visit schedule.

- Have a substance abuse problem that would interfere with taking the medications

correctly or attending the clinic visits.

- Are enrolled in another study.

- Cannot take medications by mouth or absorb drugs.

- Have hepatitis.

- Have a serious medical condition such as diabetes, congestive heart failure, or other

heart disease.

- Need chemotherapy or radiation therapy (except for local treatment of Kaposi's

sarcoma).

- Are taking certain medications.

- Are pregnant or breast-feeding.

Locations and Contacts

Univ of Alabama at Birmingham, Birmingham, Alabama 352942050, United States

Arizona Clinical Research Ctr Inc, Tucson, Arizona 85712, United States

Highland Gen Hosp / San Francisco Gen Hosp, Oakland, California 946021018, United States

San Francisco Gen Hosp, San Francisco, California 94110, United States

UCLA Care Ctr, Los Angeles, California 90095, United States

AIDS Healthcare Foundation, Los Angeles, California 900276069, United States

Maxine Liggins, Los Angeles, California 90042, United States

Good Samaritan Hosp, Los Angeles, California 90004, United States

THE Clinic, Los Angeles, California 90008, United States

Longbeach Memorial Med Ctr, Longbeach, California 90806, United States

Georgetown Univ Med Ctr, Washington, District of Columbia 20007, United States

IDC Research Initiative, Altamonte Springs, Florida 32701, United States

Univ of Miami School of Medicine, Miami, Florida 33136, United States

Children's Diagnostic Treatment Ctr, Fort Lauderdale, Florida 33301, United States

Infectious Disease Research Institute, Tampa, Florida 33614, United States

Community Health Care, Fort Lauderdale, Florida 33306, United States

South Shore Hosp, Miami, Florida 33139, United States

Immunity Care and Research Inc, Plantation, Florida 33324, United States

Comprehensive Care Center, Fort Lauderdale, Florida 33316, United States

Daniel Seekins, Tampa, Florida 33607, United States

Orange County Health Dept, Orlando, Florida 32805, United States

AIDS Research Consortium of Atlanta, Atlanta, Georgia 30308, United States

Ponce de Leon Ctr, Atlanta, Georgia 30308, United States

Philip Brachman, Atlanta, Georgia 30309, United States

Rush Presbyterian - Saint Luke's Med Ctr, Chicago, Illinois 60612, United States

Cook County Hosp, Chicago, Illinois 60614, United States

HIV Outpatient Clinics / LA State Univ Med Ctr, New Orleans, Louisiana 70112, United States

Beth Israel Deaconess Med Ctr, Boston, Massachusetts 02215, United States

Univ of Missouri at Kansas City School of Medicine, Kansas City, Missouri 64108, United States

South Jersey Infectious Diseases Inc, Somers Point, New Jersey 08244, United States

Carolinas Med Ctr, Charlotte, North Carolina 28232, United States

WNC Community Health Services, Asheville, North Carolina 28806, United States

Summa Health System, Akron, Ohio 44304, United States

MCP Hahnemann Univ Hosp, Philadelphia, Pennsylvania 19102, United States

Miriam Hosp, Providence, Rhode Island 02906, United States

Univ of Texas Southwestern Med Ctr, Dallas, Texas 75235, United States

Univ TX San Antonio Health Science Ctr, San Antonio, Texas 782847881, United States

Thomas Street Clinic, Houston, Texas 77009, United States

Hampton Roads Med Specialists, Hampton, Virginia 23666, United States

Additional Information

Starting date: September 1999
Last updated: June 23, 2005

Page last updated: June 20, 2008

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