The purpose of this study is to determine the safety and effectiveness of a high dose of ABT-378/ritonavir

Condition	Treatment or Intervention	Phase
HIV Infections	Drug: Lopinavir/ritonavir  Drug: Ritonavir	Phase III

Further Study Details: 

Expected Total Enrollment:  36

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion:

• HIV positive
• Are at least 18 years old
• Subject has not been treated for an active AIDS-defining opportunistic infection within 15 days of screening
• HIV RNA level > 1000 copies/mL
• Previous therapy with at least one protease inhibitor, at least one non-nucleoside reverse transcriptase inhibitor and at least one nucleoside reverse transcriptase inhibitor

Exclusion:

• Subject is pregnant or breast-feeding
• Subject has received an investigational drug within 30 days prior to screening
• Have a history of pancreatitis
• History of intolerance to ritonavir
• Abnormal laboratory tests at screening

California
      UCSD Treatment Center, San Diego,  California,  92103-6329,  United States
Maryland
      Johns Hopkins Hospital, Baltimore,  Maryland,  21287,  United States
North Carolina
      The University of North Carolina at Chapel Hill, Chapel Hill,  North Carolina,  27599,  United States
France
      Hopital Pitie-Salpetriere, Paris,  75651,  France
      Hopital Pitie-Salpetriere, Paris,  75651,  France
      Hospital Europeen Georges Pompidou, Paris,  75908,  France
Spain
      Hospital Clinico de Barcelona, Barcelona,  08036,  Spain
      Ciutat Sanitaria de Bellvitge, Barcelona,  08907,  Spain

Study ID Numbers:  M99-049
Record last reviewed:  September 2003
Last Updated:  October 13, 2004
Record first received:  June 3, 2002
ClinicalTrials.gov Identifier:  NCT00038636
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08