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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00004981
• Other study ID #: 308A
• Secondary ID: ESS40005
• Status: Active, not recruiting
• Phase: Phase 3
• First received: March 13, 2000
• Last updated: June 23, 2005

Study information

• Verified date: June 2001
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 230
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Abacavir sulfate, Lamivudine and Zidovudine

• Lamivudine/Zidovudine

• Abacavir sulfate

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Glaxo Wellcome

Country where clinical trial is conducted

United States,