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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified June 2001 by NIH AIDS Clinical Trials Information Service.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

NIH AIDS Clinical Trials Information Service

ClinicalTrials.gov Identifier:

NCT00004981

First received: March 13, 2000

Last updated: June 23, 2005

Last verified: June 2001

History of Changes

Tracking Information
First Received Date ^ICMJE	March 13, 2000
Last Updated Date	June 23, 2005
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00004981 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety and Effectiveness of Three Anti-HIV Drugs Combined in One Pill (Trizivir)
Official Title ^ICMJE	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
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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Endpoint Classification: Safety Study Primary Purpose: Treatment
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Drug: Abacavir sulfate, Lamivudine and Zidovudine Drug: Lamivudine/Zidovudine Drug: Abacavir sulfate
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	230
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00004981
Other Study ID Numbers ^ICMJE	308A, ESS40005
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Glaxo Wellcome
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	June 2001
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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