Clinical trial NCT00004578: ABT-378/Ritonavir in Combination With Reverse Transcriptase Inhibitors in Antiretroviral Naïve HIV-Infected Subjects
Official title: Phase I/II Study of ABT-378/Ritonavir in Combination With Reverse Transcriptase Inhibitors in Antiretroviral Naive HIV-Infected Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: HIV Infections
Keywords: Stavudine
HIV Protease Inhibitors
Ritonavir
Lamivudine
Reverse Transcriptase Inhibitors
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria

* 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

Exclusion Criteria

* 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

Primary outcomes:
measure: Proportion of subjects with viral load below the limit of quantitation
timeFrame: 24 weeks
measure: Time to loss of virologic response
timeFrame: 48 weeks
Secondary outcomes:
measure: Proportion of subjects with viral load below the limit of quantitation at each visit
timeFrame: At each visit
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Pacific Oaks Research
state: California
city: Denver
country: United States
facility: University of Colorado Health Sciences Center
state: Colorado
city: Atlanta
country: United States
facility: AIDS Research Consortium of Atlanta
state: Georgia
city: Chicago
country: United States
facility: Northwestern University Medical School
state: Illinois
city: Chicago
country: United States
facility: Rush-Presbyterian-St. Luke's Medical Center
state: Illinois
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: New York
country: United States
facility: Cornell Clinical Trials Unit - Chelsea Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: Abbott
name: George Hanna, MD
role: STUDY_DIRECTOR
References:
citation: Murphy R, King M, Brun S, Orth K, Hicks C, Eron J, Thommes J, Gulick R, Thompson M, White C, Benson C, Hammer S, Kessler H, Bertz R, Hsu A, Kempf D, Sun E, Japour A. ABT-378/ritonavir therapy in antiretroviral-naive HIV-I infected patients for 24 weeks. Conf Retroviruses Opportunistic Infect. 1999 Jan 31-Feb 4;6th:69 (abstract no 15)
citation: Murphy RL, Brun S, Hicks C, Eron JJ, Gulick R, King M, White AC Jr, Benson C, Thompson M, Kessler HA, Hammer S, Bertz R, Hsu A, Japour A, Sun E. ABT-378/ritonavir plus stavudine and lamivudine for the treatment of antiretroviral-naive adults with HIV-1 infection: 48-week results. AIDS. 2001 Jan 5;15(1):F1-9. doi: 10.1097/00002030-200101050-00002.