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

Status unconfirmed · Phase 3

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00004981

Run by

Glaxo Wellcome

People needed

230

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• AIDS Healthcare Foundation — Los Angeles, California, United States
• Tower Infectious Disease Med Ctr — Los Angeles, California, United States
• Robert Scott MD — Oakland, California, United States
• St Lukes Medical Group — San Diego, California, United States
• Georgetown Univ Med Ctr — Washington D.C., District of Columbia, United States
• Whitman Walker Clinic — Washington D.C., District of Columbia, United States
• Univ of Miami School of Medicine — Miami, Florida, United States
• Specialty Med Care Ctrs of South Florida Inc — Miami, Florida, United States
• Saint Josephs Comprehensive Research Institute — Tampa, Florida, United States
• AIDS Research Consortium of Atlanta — Atlanta, Georgia, United States
• Rush Presbyterian - Saint Luke's Med Ctr — Chicago, Illinois, United States
• New England Med Ctr — Boston, Massachusetts, United States
• Research Med Ctr — Kansas City, Missouri, United States
• Addiction Research and Treatment Corp — Brooklyn, New York, United States
• Saint Vincent's Hosp and Med Ctr — New York, New York, United States
• St Luke Roosevelt Hosp — New York, New York, United States
• Lehigh Valley Hosp — Allentown, Pennsylvania, United States
• Hahnemann Univ Hosp — Philadelphia, Pennsylvania, United States
• Anderson Clinical Research — Pittsburgh, Pennsylvania, United States
• Burnside Clinic — Columbia, South Carolina, United States
• Univ of Tennessee — Memphis, Tennessee, United States
• Nashville Health Management Foundation / Vanderbilt Univ — Nashville, Tennessee, United States
• Nicholas Bellos — Dallas, Texas, United States
• Univ of Texas Med Branch — Galveston, Texas, United States
• Therapeutic Concepts — Houston, Texas, United States

Full record on ClinicalTrials.gov

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