A Study to Compare Two Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Previously Received Anti-HIV Treatment

This study has been completed.

First Received on November 2, 1999. Last Updated on February 19, 2009 History of Changes

Sponsor:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00004581

Purpose

The purpose of this study is to compare the safety and effectiveness of 2 anti-HIV drug combinations in HIV-infected patients. Both combinations will include nevirapine (NVP), 2 nucleoside reverse transcriptase inhibitors (NRTIs), and at least 1 protease inhibitor (PI). One combination will include a new protease inhibitor, ABT-378, combined in a capsule with ritonavir (RTV).

Condition	Intervention	Phase
HIV Infections	Drug: Lopinavir/Ritonavir Drug: Nevirapine	Phase III

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Primary Purpose: Treatment
Official Title:	A Randomized, Open-Label, Phase III Study of ABT-378/Ritonavir in Combination With Nevirapine and Two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) vs. Investigator Selected Protease Inhibitor(s) in Combination With Nevirapine and Two NRTIs in Antiretroviral-Experienced HIV-Infected Subjects

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS HIV/AIDS Medicines

Drug Information available for: Nevirapine Ritonavir Lopinavir

U.S. FDA Resources

Further study details as provided by Abbott:

Estimated Enrollment:

300

Detailed Description:

Patients receive 1 of the following:

ABT-378/RTV plus NVP plus 2 NRTIs; or
Investigator-selected PI(s) plus NVP plus 2 NRTIs.

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

Are at least 12 years old.
Are HIV-positive and have a viral load (level of HIV in the blood) of 1,000 - 100,000 copies/ml.
Are currently taking an anti-HIV drug combination that includes 1 PI and 2 NRTIs, and that has not been changed in at least 12 weeks.
Are naive to (have never taken) at least 1 NRTI, other than zalcitabine or abacavir.
Agree to abstinence or use of an effective barrier method (e.g., condom) of birth control.

Exclusion Criteria

Patients will not be eligible for this study if they:

Have an active illness.
Have received treatment for any active opportunistic (AIDS-related) infection within 30 days of study entry.
Have ever received a nonnucleoside reverse transcriptase inhibitor (NNRTI).
Have received investigational (not yet approved by the FDA) drugs within 30 days of study entry.
Have received treatment with a PI other than their current PI.
Are receiving chemotherapy for cancer.
Are pregnant or breast-feeding.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004581

Show 88 Study Locations

Sponsors and Collaborators

Abbott

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00004581 History of Changes
Other Study ID Numbers:	285D, M98-888
Study First Received:	November 2, 1999
Last Updated:	February 19, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abbott:

Drug Therapy, Combination
Nevirapine
HIV Protease Inhibitors
Ritonavir

Reverse Transcriptase Inhibitors
Anti-HIV Agents
ABT 378

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
Protease Inhibitors
Ritonavir

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

ClinicalTrials.gov processed this record on February 09, 2012