Clinical trial NCT00004981: Safety and Effectiveness of Three Anti-HIV Drugs Combined in One Pill (Trizivir)
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: HIV Infections
Keywords: Drug Therapy, Combination
Zidovudine
Drug Administration Schedule
Lamivudine
RNA, Viral
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Viral Load
Combivir
abacavir
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief 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.

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 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.

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