ABT-378/Ritonavir and Efavirenz in HIV-Infected Patients Who Have Taken More Than One Protease Inhibitor in the Past - Full Text View

ABT-378/Ritonavir and Efavirenz in HIV-Infected Patients Who Have Taken More Than One Protease Inhibitor in the Past

This study has been completed.

Sponsored by:	ViRx
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00004582

Purpose

The purpose of this study is to see if ABT-378/ritonavir plus efavirenz is safe and effective in lowering the amount of HIV in the blood of patients who have been treated with more than 1 protease inhibitor (PI).

Condition	Intervention	Phase
HIV Infections	Drug: Lopinavir/Ritonavir Drug: Efavirenz	Phase II

MedlinePlus related topics:

AIDS

Drug Information available for:

Efavirenz Ritonavir Lopinavir

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Safety Study

Official Title:	A Phase II Study of ABT-378/Ritonavir and Efavirenz in Multiple Protease Inhibitor-Experienced Subjects

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Detailed Description:

All patients take ABT-378/ritonavir and efavirenz; there are no placebos in this study. Patients take study medications for 48 weeks, during which time there will be 15 study visits. There is a possibility of a study extension after 48 weeks.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

Are HIV-positive.
Have a viral load (level of HIV in the blood) of at least 1,000 copies/ml.
Have been receiving stable (no changes) anti-HIV treatment that includes at least 1 PI for at least 8 weeks prior to study entry.
Have received more than 1 PI for at least 12 weeks each at some time in the past.

Exclusion Criteria

Patients will not be eligible for this study if they:

Have had any active opportunistic (AIDS-related) infections within the past 30 days.
Have ever received nonnucleoside reverse transcriptase inhibitors (NNRTIs), such as delavirdine, nevirapine, or efavirenz.
Have received certain medications.
Are pregnant or breast-feeding.
Abuse alcohol or drugs.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004582

Locations


United States, California
	ViRx Inc
	San Francisco, California, United States, 94103

Sponsors and Collaborators

ViRx

More Information

Study ID Numbers:	285E, M98-957
First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004582
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

HIV Protease Inhibitors

Ritonavir

Reverse Transcriptase Inhibitors

Anti-HIV Agents

Viral Load

ABT 378

efavirenz

Study placed in the following topic categories:

Virus Diseases

Efavirenz

Sexually Transmitted Diseases, Viral

Lopinavir

Ritonavir

HIV Infections

Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome

Retroviridae Infections

Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Anti-Infective Agents

RNA Virus Infections

HIV Protease Inhibitors

Slow Virus Diseases

Anti-HIV Agents

Immune System Diseases

Molecular Mechanisms of Pharmacological Action

Enzyme Inhibitors

Infection

Antiviral Agents

Pharmacologic Actions

Reverse Transcriptase Inhibitors

Protease Inhibitors

Anti-Retroviral Agents

Therapeutic Uses

Lentivirus Infections

Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on November 30, 2008