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

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	February 19, 2009
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00004581 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	A Study to Compare Two Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Previously Received Anti-HIV Treatment
Official Title ^ICMJE	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
Brief Summary	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).
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.
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Safety Study
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Drug: Lopinavir/Ritonavir Drug: Nevirapine
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	300
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	12 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Australia, Austria, Brazil, Canada, Denmark, France, Germany, Poland, Puerto Rico, South Africa, Spain, Switzerland, United Kingdom

Administrative Information
NCT ID ^ICMJE	NCT00004581
Responsible Party
Study ID Numbers ^ICMJE	285D, M98-888
Study Sponsor ^ICMJE	Abbott
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Abbott
Verification Date	February 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP