Safety and Effectiveness of Three Anti-HIV Drugs Combined in One Pill (Trizivir)
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Abacavir sulfate, Lamivudine and Zidovudine (Drug); Lamivudine/Zidovudine (Drug); Abacavir sulfate (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Glaxo Wellcome
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.
Clinical Details
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
Study design: Treatment, Safety Study
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): 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.
Locations and Contacts
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
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
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
Hahnemann Univ Hosp, Philadelphia, Pennsylvania 191021192, United States
Lehigh Valley Hosp, Allentown, Pennsylvania 18105, 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
Univ of Texas Med Branch, Galveston, Texas 77555, United States
Therapeutic Concepts, Houston, Texas 77004, United States
Nicholas Bellos, Dallas, Texas 75246, United States
Additional Information
Last updated: June 23, 2005
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