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

This study has been completed.

First Received on May 29, 2002. Last Updated on July 26, 2006 History of Changes

Sponsor:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00038220

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Drug: Lopinavir/ritonavir Drug: Efavirenz Drug: Lamivudine Drug: Tenofovir DF	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Lamivudine Tenofovir Efavirenz Ritonavir Lopinavir Tenofovir disoproxil Tenofovir Disoproxil Fumarate

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:

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

Estimated Enrollment:	40
Study Start Date:	July 2000

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00038220

Locations

United States, New York
Aaron Diamond AIDS Research Center - Rockefeller University
New York, New York, United States, 10021

Sponsors and Collaborators

Abbott

Investigators

Study Director:

Scott Brun, M.D.

Head, Antiviral Global Project Team

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00038220 History of Changes
Obsolete Identifiers:	NCT00006189
Other Study ID Numbers:	M00-154
Study First Received:	May 29, 2002
Last Updated:	July 26, 2006
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abbott:

HIV

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Lamivudine
Tenofovir
Tenofovir disoproxil
Efavirenz

Ritonavir
Lopinavir
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents
HIV Protease Inhibitors
Protease Inhibitors

ClinicalTrials.gov processed this record on February 12, 2012