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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00005106
First received: April 6, 2000
Last updated: June 23, 2005
Last verified: November 2000
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: Lamivudine/Zidovudine
Drug: Abacavir sulfate
Drug: Nelfinavir mesylate
Drug: Lamivudine
Drug: Stavudine
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
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

Resource links provided by NLM:


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

Estimated Enrollment: 230
Study Start Date: September 1999
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

Ages Eligible for Study:   18 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 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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005106

  Hide Study Locations
Locations
United States, Alabama
Univ of Alabama at Birmingham
Birmingham, Alabama, United States, 352942050
United States, Arizona
Arizona Clinical Research Ctr Inc
Tucson, Arizona, United States, 85712
United States, California
Longbeach Memorial Med Ctr
Longbeach, California, United States, 90806
AIDS Healthcare Foundation
Los Angeles, California, United States, 900276069
UCLA Care Ctr
Los Angeles, California, United States, 90095
Maxine Liggins
Los Angeles, California, United States, 90042
Good Samaritan Hosp
Los Angeles, California, United States, 90004
THE Clinic
Los Angeles, California, United States, 90008
Highland Gen Hosp / San Francisco Gen Hosp
Oakland, California, United States, 946021018
San Francisco Gen Hosp
San Francisco, California, United States, 94110
United States, District of Columbia
Georgetown Univ Med Ctr
Washington, District of Columbia, United States, 20007
United States, Florida
IDC Research Initiative
Altamonte Springs, Florida, United States, 32701
Community Health Care
Fort Lauderdale, Florida, United States, 33306
Children's Diagnostic Treatment Ctr
Fort Lauderdale, Florida, United States, 33301
Comprehensive Care Center
Fort Lauderdale, Florida, United States, 33316
South Shore Hosp
Miami, Florida, United States, 33139
Univ of Miami School of Medicine
Miami, Florida, United States, 33136
Orange County Health Dept
Orlando, Florida, United States, 32805
Immunity Care and Research Inc
Plantation, Florida, United States, 33324
Infectious Disease Research Institute
Tampa, Florida, United States, 33614
Daniel Seekins
Tampa, Florida, United States, 33607
United States, Georgia
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States, 30308
Ponce de Leon Ctr
Atlanta, Georgia, United States, 30308
Philip Brachman
Atlanta, Georgia, United States, 30309
United States, Illinois
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States, 60612
Cook County Hosp
Chicago, Illinois, United States, 60614
United States, Louisiana
HIV Outpatient Clinics / LA State Univ Med Ctr
New Orleans, Louisiana, United States, 70112
United States, Massachusetts
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, United States, 02215
United States, Missouri
Univ of Missouri at Kansas City School of Medicine
Kansas City, Missouri, United States, 64108
United States, New Jersey
South Jersey Infectious Diseases Inc
Somers Point, New Jersey, United States, 08244
United States, North Carolina
WNC Community Health Services
Asheville, North Carolina, United States, 28806
Carolinas Med Ctr
Charlotte, North Carolina, United States, 28232
United States, Ohio
Summa Health System
Akron, Ohio, United States, 44304
United States, Pennsylvania
MCP Hahnemann Univ Hosp
Philadelphia, Pennsylvania, United States, 19102
United States, Rhode Island
Miriam Hosp
Providence, Rhode Island, United States, 02906
United States, Texas
Univ of Texas Southwestern Med Ctr
Dallas, Texas, United States, 75235
Thomas Street Clinic
Houston, Texas, United States, 77009
Univ TX San Antonio Health Science Ctr
San Antonio, Texas, United States, 782847881
United States, Virginia
Hampton Roads Med Specialists
Hampton, Virginia, United States, 23666
Sponsors and Collaborators
Glaxo Wellcome
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00005106     History of Changes
Other Study ID Numbers: 264P, ESS40002
Study First Received: April 6, 2000
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Drug Therapy, Combination
Zidovudine
Stavudine
HIV Protease Inhibitors
Lamivudine
Nelfinavir
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Adipose Tissue
Lipodystrophy
abacavir

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Zidovudine
Stavudine
Lamivudine
Reverse Transcriptase Inhibitors
Abacavir
Lamivudine, zidovudine drug combination
Nelfinavir
HIV Protease Inhibitors
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents
Protease Inhibitors

ClinicalTrials.gov processed this record on July 20, 2014