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: November 2, 1999 Last Updated: 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:	Treatment, Safety Study
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:

MedlinePlus related topics: AIDS 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

Study ID Numbers:	285D, M98-888
Study First Received:	November 2, 1999
Last Updated:	February 19, 2009
ClinicalTrials.gov Identifier:	NCT00004581 History of Changes
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:

Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Infection
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors
HIV Protease Inhibitors
RNA Virus Infections
Anti-HIV Agents

Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Protease Inhibitors
Virus Diseases
Nevirapine
HIV Infections
Ritonavir
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on November 09, 2009