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

This study is no longer recruiting patients.

Sponsored by: Glaxo Wellcome
Information provided by: AIDS Clinical Trials Information Service

Purpose

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.

Condition Treatment or Intervention Phase
HIV Infections
 Drug: Abacavir sulfate, Lamivudine and Zidovudine
 Drug: Lamivudine/Zidovudine
 Drug: Abacavir sulfate
Phase III

MedlinePlus related topics:  AIDS

Study Type: Interventional
Study Design: Treatment, Safety Study

Official Title: A Phase IIIB Randomized, Multicenter Study of the Efficacy and Safety of Combivir 1 Tablet po bid Plus Ziagen 300mg po bid Versus an Abacavir 300mg/Lamivudine 150mg/Zidovudine 300mg Combination Tablet po bid, Administered for 24 Weeks in Subjects with HIV-1 Infection

Further Study Details: 

Expected Total Enrollment:  230

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.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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

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.

Location Information


California
      St Lukes Medical Group, San Diego,  California,  92101,  United States

      Robert Scott MD, Oakland,  California,  94609,  United States

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

      Tower Infectious Disease Med Ctr, Los Angeles,  California,  90048,  United States

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

      Whitman Walker Clinic, Washington,  District of Columbia,  20009,  United States

Florida
      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

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

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

Massachusetts
      New England Med Ctr, Boston,  Massachusetts,  02111,  United States

Missouri
      Research Med Ctr, Kansas City,  Missouri,  64111,  United States

New York
      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

      Addiction Research and Treatment Corp, Brooklyn,  New York,  11201,  United States

Pennsylvania
      Hahnemann Univ Hosp, Philadelphia,  Pennsylvania,  191021192,  United States

      Lehigh Valley Hosp, Allentown,  Pennsylvania,  18105,  United States

      Anderson Clinical Research, Pittsburgh,  Pennsylvania,  15213,  United States

South Carolina
      Burnside Clinic, Columbia,  South Carolina,  29206,  United States

Tennessee
      Univ of Tennessee, Memphis,  Tennessee,  38163,  United States

      Nashville Health Management Foundation / Vanderbilt Univ, Nashville,  Tennessee,  37203,  United States

Texas
      Univ of Texas Med Branch, Galveston,  Texas,  77555,  United States

      Therapeutic Concepts, Houston,  Texas,  77004,  United States

      Nicholas Bellos, Dallas,  Texas,  75246,  United States

More Information

Study ID Numbers:  308A; ESS40005
Record last reviewed:  June 2001
Last Updated:  October 13, 2004
Record first received:  March 13, 2000
ClinicalTrials.gov Identifier:  NCT00004981
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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