CClinicalTrials.gg
Status unknownNCT00004981Updated Jun 24, 2005

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

A Phase 3 interventional study of Abacavir sulfate, Lamivudine and Zidovudine and Lamivudine/Zidovudine in HIV Infections, sponsored by Glaxo Wellcome. Status unknown at 25 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2005-06-24.

Sponsored by Glaxo Wellcome · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2001), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
230
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Patients are randomized to receive either the triple combination tablet (Trizivir) or to receive Combivir plus abacavir as a separate tablet. Patients take their study medications for 24 weeks.

02

Conditions studied

  • HIV Infections

Browse trials for

Keywords

  • Drug Therapy, Combination
  • Zidovudine
  • Drug Administration Schedule
  • Lamivudine
  • RNA, Viral
  • Reverse Transcriptase Inhibitors
  • Anti-HIV Agents
  • Viral Load
  • Combivir
  • abacavir
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 230 is above the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Glaxo Wellcome is the lead sponsor of 72 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Enrollment
230 participants

Interventions

  • DrugAbacavir sulfate, Lamivudine and Zidovudine
  • DrugLamivudine/Zidovudine
  • DrugAbacavir sulfate
06

Study locations

25 sites
  • AIDS Healthcare Foundation
    Los Angeles, California 900276069, United States
  • Tower Infectious Disease Med Ctr
    Los Angeles, California 90048, United States
  • Robert Scott MD
    Oakland, California 94609, United States
  • St Lukes Medical Group
    San Diego, California 92101, United States
  • Georgetown Univ Med Ctr
    Washington, District of Columbia 20007, United States
  • Whitman Walker Clinic
    Washington, District of Columbia 20009, United States
  • Univ of Miami School of Medicine
    Miami, Florida 33136, United States
  • Specialty Med Care Ctrs of South Florida Inc
    Miami, Florida 33142, United States
  • Saint Josephs Comprehensive Research Institute
    Tampa, Florida 33607, United States
  • AIDS Research Consortium of Atlanta
    Atlanta, Georgia 30308, United States
  • Rush Presbyterian - Saint Luke's Med Ctr
    Chicago, Illinois 60612, United States
  • New England Med Ctr
    Boston, Massachusetts 02111, United States
  • Research Med Ctr
    Kansas City, Missouri 64111, United States
  • Addiction Research and Treatment Corp
    Brooklyn, New York 11201, United States
  • Saint Vincent's Hosp and Med Ctr
    New York, New York 10011, United States
  • St Luke Roosevelt Hosp
    New York, New York 10011, United States
  • Lehigh Valley Hosp
    Allentown, Pennsylvania 18105, United States
  • Hahnemann Univ Hosp
    Philadelphia, Pennsylvania 191021192, United States
  • Anderson Clinical Research
    Pittsburgh, Pennsylvania 15213, United States
  • Burnside Clinic
    Columbia, South Carolina 29206, United States
  • Univ of Tennessee
    Memphis, Tennessee 38163, United States
  • Nashville Health Management Foundation / Vanderbilt Univ
    Nashville, Tennessee 37203, United States
  • Nicholas Bellos
    Dallas, Texas 75246, United States
  • Univ of Texas Med Branch
    Galveston, Texas 77555, United States
  • Therapeutic Concepts
    Houston, Texas 77004, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00004981
Lead sponsor
Glaxo Wellcome
First posted
Aug 31, 2001
Last update
Jun 24, 2005
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2001. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion