Safety and Effectiveness of Three Anti-HIV Drugs Combined in One Pill (Trizivir) - Article Azidothymidine Capsule; AZT Capsule; Compound S Capsule; Retrovir Capsule
Clinical Trial: Safety and Effectiveness of Three Anti-HIV Drugs Combined in One Pill (Trizivir)
This study is no longer recruiting patients.
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: 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
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.
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
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.
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.
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
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
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
Cache Date: April 9, 2005