Completed

Phase I/II Study of ABT-378/Ritonavir in Combination With Reverse Transcriptase Inhibitors in Antiretroviral Naive HIV-Infected Patients

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What is being tested

Lopinavir/Ritonavir

+ Lamivudine

+ Stavudine

Drug
Who is being recruted

Blood-Borne Infections+11

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1 & 2
Interventional
Study Start: November 1997
See protocol details

Summary

Principal SponsorAbbott
Last updated: April 3, 2008
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 1997

Actual date on which the first participant was enrolled.

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

NCT00004578
Principal SponsorAbbott
Last updated: April 3, 2008
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsHIV Infections

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Group 1, n=32 initiated with ABT-378 & ritonavir; after 3 wks stavudine and lamivudine was added.

Group II

Active Comparator
Group II patients (n=68) to be randomized after all Group I patients are enrolled and safety analysis is completed.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 10 locations

Pacific Oaks Research

Beverly Hills, United StatesOpen Pacific Oaks Research in Google Maps

University of Colorado Health Sciences Center

Denver, United States

AIDS Research Consortium of Atlanta

Atlanta, United States

Northwestern University Medical School

Chicago, United States
Completed10 Study Centers