Clinical trial NCT00004580: A Study of ABT-378/Ritonavir Combination in HIV-Infected Patients Who Have Taken Protease Inhibitors
Official title: Phase I/II Study of ABT-378/Ritonavir in Protease Inhibitor Experienced HIV-Infected Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Keywords: Drug Therapy, Combination
Nevirapine
HIV Protease Inhibitors
Ritonavir
Reverse Transcriptase Inhibitors
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if it is safe and effective to give ABT-378/ritonavir combination plus nevirapine plus two nucleoside transcriptase inhibitors to HIV-infected patients who previously have taken protease inhibitors. This study also examines how the body handles this combination of anti-HIV drugs.


Eligibility criteria: Inclusion Criteria

Concurrent Medication:

Allowed:

- Antiretroviral regimen containing a protease inhibitor and one or two nucleoside reverse transcriptase inhibitors that has not changed in the last 12 weeks.

Patients must have:

- HIV infection with plasma HIV RNA of at least 1,000 copies/ml and less than or equal to 100,000 copies/ml at screening.

Prior Medication:

Allowed:

Naive to or has had less than 8 weeks of at least one nucleoside reverse transcriptase inhibitor and an acceptable regimen of two nucleoside reverse transcriptase inhibitors.

Exclusion Criteria

Concurrent Medication:

Excluded:

* Medications that are contraindicated with ABT-378/ritonavir for the duration of the study, such as midazolam, triazolam, terfenadine, astemizole, cisapride, pimozide, ergotamine and dihydroergotamine.
* Over-the-counter medicine or alcohol, without knowledge or permission of the investigator.

Patients with the following prior conditions are excluded:

* Evidence of acute illness determined by vital signs, physical examination, or laboratory results.
* Clinically significant abnormal ECG results.
* Positive test result for drug abuse with the exception of cannabis, unless the investigator anticipates cannabis use will interfere with compliance with the study.

Prior Medication:

Excluded:

* Investigational drugs with the exception of Amprenavir within 28 days prior to the initiation of study dosing.
* Treatment with a non-nucleoside reverse transcriptase inhibitor.
* Treatment with a protease inhibitor different from the current protease inhibitor for more than 6 weeks prior to current regimen.
* Treatment with more than one protease inhibitor concurrently.

Risk Behavior:

Excluded:

* Active substance abuse, alcohol abuse, psychiatric illness.
* Presumption, by investigator, of poor compliance to regimen.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Pacific Oaks Research
state: California
city: San Francisco
country: United States
facility: San Francisco Gen Hosp / UCSF AIDS Program
state: California
city: Denver
country: United States
facility: Univ of Colorado Health Sciences Ctr
state: Colorado
city: Atlanta
country: United States
facility: AIDS Research Consortium of Atlanta
state: Georgia
city: Chicago
country: United States
facility: Rush Presbyterian St Lukes Med Ctr / Sect Infect Dise
state: Illinois
city: Chapel Hill
country: United States
facility: Univ North Carolina at Chapel Hill / Dept of Medicine
state: North Carolina
city: Durham
country: United States
facility: Duke Univ Med Ctr / Infectious Disease Clinic
state: North Carolina
city: Cincinnati
country: United States
facility: Univ of Cincinnati Med Ctr / Holmes Div Mail Loc 0405
state: Ohio
city: Pittsburgh
country: United States
facility: Univ of Pittsburgh
state: Pennsylvania
city: Annandale
country: United States
facility: Infectious Disease Physicians Inc
state: Virginia
Study officials:
References: