ABT-378/Ritonavir in Combination With Reverse Transcriptase Inhibitors in Antiretroviral Naïve HIV-Infected Subjects

Completed · Phase 1/Phase 2

Conditions studied: HIV Infections

In brief

To assess the safety, tolerability and antiviral activity of lopinavir/ritonavir when administered orally in antiretroviral-HIV-1 infected subjects.

Key facts

Study ID

NCT00004578

Run by

Abbott

People needed

100

Starts

1997-11-01

Expected to finish

2005-04-01

Last updated by the study team

2008-04-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• HIV-1 positive
• antiretroviral-adult males
• non-pregnant
• non-lactating females at least 18-years old with plasma HIV-1 RNA > 5000 copies/mL, who were not acutely ill

You may not qualify if…

• History of:
• prior antiretroviral therapy
• significant drug hypersensitivity
• psychiatric illness that precludes compliance
• an active substance abuser
• positive test results for drug abuse
• abnormal lab test results (hemoglobin, absolute neutrophil count, platelet count, SGPT/AST or SGPT/ALT, creatinine, fasting triglycerides, significant abnormal ECG results
• pregnancy or lactating female
• received another investigational drug within 28 days of study initiation
• unlikely to comply or unsuitable candidate in the opinion of the investigator

Where it is running

• Pacific Oaks Research — Beverly Hills, California, United States
• University of Colorado Health Sciences Center — Denver, Colorado, United States
• AIDS Research Consortium of Atlanta — Atlanta, Georgia, United States
• Northwestern University Medical School — Chicago, Illinois, United States
• Rush-Presbyterian-St. Luke's Medical Center — Chicago, Illinois, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Cornell Clinical Trials Unit - Chelsea Center — New York, New York, United States
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Baylor College of Medicine — Houston, Texas, United States

Full record on ClinicalTrials.gov

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