The purpose of this study is to see if it is safe and effective to give ABT-378/ritonavir to HIV-infected patients who have never been treated with anti-HIV drugs. This study also examines how the body handles ABT-378/ritonavir.

Condition	Treatment or Intervention	Phase
HIV Infections	Drug: Lopinavir/Ritonavir  Drug: Lamivudine  Drug: Stavudine	Phase I

Further Study Details: 

Expected Total Enrollment:  32

This is a Phase I/II randomized, ABT-378 dose-blinded, multicenter study of ABT-378/ritonavir in combination with stavudine (d4T) and lamivudine (3TC) in 32 HIV-infected otherwise healthy men and women.

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

Criteria

Inclusion Criteria

Patients must have:

• Documented HIV infection.
• HIV RNA equal to or greater than 5,000 copies/ml.

Exclusion Criteria

Co-existing Condition: Patients with the following conditions or symptoms are excluded:

• Evidence of acute infection, as measured by vital signs, physical examination, and laboratory assessments.
• Clinically significant abnormal ECG results.
• Positive Hepatitis B surface antigen or anti-HCV antibodies test at screening. Concurrent Medication: Excluded:
• Midazolam, triazolam, terfenadine, astemizole, cisapride, pimozide, ergotamine, and dihydroergotamine.
• Over-the-counter medications, without permission from the lead investigator.

Patients with the following prior conditions are excluded:

• Prior antiretroviral therapy.
• History of significant drug hypersensitivity.
• History of psychiatric illness that would preclude compliance with the protocol.

Prior Medication: Excluded:

• Midazolam, triazolam, terfenadine, astemizole, cisapride, pimozide, ergotamine, and dihydroergotamine within 28 days prior to drug administration.
• Investigational drugs and over-the-counter medicine within 28 days prior to drug administration.
• Antiretroviral therapy.

Risk Behavior: Excluded: Active substance abuse. (NOTE:

• With the exception of cannabis, unless the lead investigator anticipates cannabis use will interfere with compliance with the study.)

California
      Pacific Oaks Research, Beverly Hills,  California,  90211,  United States
Illinois
      Northwestern Univ Med Ctr, Chicago,  Illinois,  60611,  United States
Massachusetts
      New England Deaconess Hosp, Boston,  Massachusetts,  02215,  United States
North Carolina
      Duke Univ Med Ctr, Durham,  North Carolina,  27710,  United States
      Univ of North Carolina / Infectious Disease Division, Chapel Hill,  North Carolina,  27599,  United States

Study ID Numbers:  285A; M97-720
Record last reviewed:  June 1998
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00004578
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08