Safety and Effectiveness of Three Anti-HIV Drugs Combined in One Pill (Trizivir)

NCT00004981 | Unknown Phase 3

• 2 other identifiers: 308AESS40005
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 25

Brief Summary

The purpose of this study is to look at the safety and effectiveness of a pill called Trizivir that is a combination of three anti-HIV drugs (zidovudine, lamivudine, and abacavir). Zidovudine and lamivudine are often given combined in one pill (Combivir). In this study, Trizivir will be compared to Combivir plus abacavir.

Conditions

HIV Infections

Keywords

Drug Therapy, Combination; Zidovudine; Drug Administration Schedule; Lamivudine; RNA, Viral; Reverse Transcriptase Inhibitors; Anti-HIV Agents; Viral Load; Combivir; abacavir

Interventions

Abacavir sulfate, Lamivudine and Zidovudine DRUG

Lamivudine/Zidovudine DRUG

Abacavir sulfate DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients may be eligible for this study if they:
• Are at least 18 years old.
• Are HIV-positive.
• Are currently receiving one of the following anti-HIV drug combinations: Combivir plus abacavir, Combivir plus abacavir plus a protease inhibitor, or Combivir plus abacavir plus a non-nucleoside reverse transcriptase inhibitor (NNRTI). Patients must have been taking this drug combination for at least the past 16 weeks. This also must be the first anti-HIV drug combination the patient has received.
• Have a viral load (level of HIV in the blood) less than or equal to 400 copies/ml.
• Have CD4+ cell count greater than 200 cells/mm3.
• Agree to use effective methods of birth control.

You may not qualify if:

• Patients will not be eligible for this study if they:
• Have been diagnosed with AIDS.
• Have a gastrointestinal disorder that makes it difficult for patients to absorb food or to take medications by mouth.
• Have hepatitis.
• Have a serious medical condition, such as diabetes, congestive heart failure, or other heart disease.
• Are allergic to any of the study drugs.
• Abuse alcohol or drugs.
• Will not be available for the entire 24-week study period.
• Are pregnant or breast-feeding.
• Have taken or will need to take certain medications, including radiation therapy, chemotherapy, drugs that affect the immune system (such as interleukin), an HIV vaccine, foscarnet, and hydroxyurea.
• Are enrolled in another experimental drug study.

Sponsors & Collaborators

• Glaxo Wellcome: lead

Study Sites (25)

AIDS Healthcare Foundation

Los Angeles, California, 900276069, United States

Location

Tower Infectious Disease Med Ctr

Los Angeles, California, 90048, United States

Location

Robert Scott MD

Oakland, California, 94609, United States

Location

St Lukes Medical Group

San Diego, California, 92101, United States

Location

Georgetown Univ Med Ctr

Washington D.C., District of Columbia, 20007, United States

Location

Whitman Walker Clinic

Washington D.C., District of Columbia, 20009, United States

Location

Univ of Miami School of Medicine

Miami, Florida, 33136, United States

Location

Specialty Med Care Ctrs of South Florida Inc

Miami, Florida, 33142, United States

Location

Saint Josephs Comprehensive Research Institute

Tampa, Florida, 33607, United States

Location

AIDS Research Consortium of Atlanta

Atlanta, Georgia, 30308, United States

Location

Rush Presbyterian - Saint Luke's Med Ctr

Chicago, Illinois, 60612, United States

Location

New England Med Ctr

Boston, Massachusetts, 02111, United States

Location

Research Med Ctr

Kansas City, Missouri, 64111, United States

Location

Addiction Research and Treatment Corp

Brooklyn, New York, 11201, United States

Location

Saint Vincent's Hosp and Med Ctr

New York, New York, 10011, United States

Location

St Luke Roosevelt Hosp

New York, New York, 10011, United States

Location

Lehigh Valley Hosp

Allentown, Pennsylvania, 18105, United States

Location

Hahnemann Univ Hosp

Philadelphia, Pennsylvania, 191021192, United States

Location

Anderson Clinical Research

Pittsburgh, Pennsylvania, 15213, United States

Location

Burnside Clinic

Columbia, South Carolina, 29206, United States

Location

Univ of Tennessee

Memphis, Tennessee, 38163, United States

Location

Nashville Health Management Foundation / Vanderbilt Univ

Nashville, Tennessee, 37203, United States

Location

Nicholas Bellos

Dallas, Texas, 75246, United States

Location

Univ of Texas Med Branch

Galveston, Texas, 77555, United States

Location

Therapeutic Concepts

Houston, Texas, 77004, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

abacavir; Lamivudine; Zidovudine; lamivudine, zidovudine drug combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides; Thymidine

Study Design

• Study Type: interventional
• Phase: phase 3
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 13, 2000
• First Posted: August 31, 2001
• Last Updated: June 24, 2005

Record last verified: 2001-06

Locations

US (25)