Effectiveness of ABT-378/Ritonavir Plus Lamivudine Plus Efavirenz Plus Tenofovir DF in HIV-Infected Patients - Tabular View

Tracking Information

First Received Date ^ICMJE

May 29, 2002

Last Updated Date

July 26, 2006

Start Date ^ICMJE

July 2000

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Proportion of subjects in each group demonstrating complete suppression of viral replication at Week 144.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00038220 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Effectiveness of ABT-378/Ritonavir Plus Lamivudine Plus Efavirenz Plus Tenofovir DF in HIV-Infected Patients

Official Title ^ICMJE

A Phase I/II, Open Label Study to Evaluate the Ability of Combination Therapy With ABT-378/Ritonavir (Kaletra), Lamivudine (Epivir), Efavirenz (Sustiva)and Tenofovir DF to Completely Suppress Viral Replication in Subjects Infected With HIV-1

Brief Summary

The purpose of this study is to see if a novel 4-drug anti-HIV combination can suppress the growth of HIV in patients infected with the virus.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

HIV Infections

Intervention ^ICMJE

Drug: Lopinavir/ritonavir
Drug: Efavirenz
Drug: Lamivudine
Drug: Tenofovir DF

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Have HIV Infection.
Age 18 to 65 years old.
Show no signs of recent illness other than HIV infection.
Agree to use a barrier method of birth control during the study and for 30 days after study.

Exclusion Criteria:

Are unable to follow study requirements (in the opinion of the investigator).
Are pregnant or breast-feeding.
Are unable to take medications by mouth.
Have chronic nausea or vomiting.
Have cancer other than Kaposi's sarcoma or basal cell carcinoma.
Have active, serious infections (other than HIV) requiring antibiotic injections within 15 days prior to screening.
Are taking any medications that are not allowed with ABT-378/r and efavirenz.
Are taking or have taken any other experimental drugs, antiretroviral drugs, or drugs that affect the immune system within 30 days of start of study without consent of the medical monitor.
Are receiving or have received radiation therapy within 30 days of start of study without consent of the medical monitor.
Have a history of drug abuse or mental illness that would prevent the patient from following the protocol requirements.
Have a history of kidney or bone disease.

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00038220

Responsible Party

Study ID Numbers ^ICMJE

M00-154

Study Sponsor ^ICMJE

Abbott

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Scott Brun, M.D.

Head, Antiviral Global Project Team

Information Provided By

Abbott

Verification Date

July 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP