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

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.

Sponsored by:	Abbott
Information provided by:	NIH AIDS Clinical Trials Information Service
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

MedlinePlus related topics:

AIDS AIDS Medicines

Drug Information available for:

Ritonavir Nevirapine Lopinavir

U.S. FDA Resources

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

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

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

Study ID Numbers:	285D, M98-888
First Received:	November 2, 1999
ClinicalTrials.gov Identifier:	NCT00004581
Health Authority:	Unspecified

Keywords provided by NIH AIDS Clinical Trials Information Service:

Drug Therapy, Combination

Nevirapine

HIV Protease Inhibitors

Ritonavir

Reverse Transcriptase Inhibitors

Anti-HIV Agents

ABT 378

Study placed in the following topic categories:

Virus Diseases

Nevirapine

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

HIV Protease Inhibitors

RNA Virus Infections

Slow Virus Diseases

Anti-HIV Agents

Molecular Mechanisms of Pharmacological Action

Immune System Diseases

Enzyme Inhibitors

Infection

Antiviral Agents

Pharmacologic Actions

Protease Inhibitors

Reverse Transcriptase Inhibitors

Anti-Retroviral Agents

Therapeutic Uses

Lentivirus Infections

Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on November 20, 2008