ClinicalTrials.gg
Sign In
CompletedNCT00004578Updated Apr 3, 2008

ABT-378/Ritonavir in Combination With Reverse Transcriptase Inhibitors in Antiretroviral Naïve HIV-Infected Subjects

A Phase 1/2 interventional study of Lopinavir/Ritonavir and Lamivudine in HIV Infections, sponsored by Abbott. Completed at 10 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-04-03.

Sponsored by Abbott · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • HIV Infections

Browse trials for

Keywords

  • Stavudine
  • HIV Protease Inhibitors
  • Ritonavir
  • Lamivudine
  • Reverse Transcriptase Inhibitors
03

In context

HIV Infections

4,340 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 100 is above the median of 83 across 3,312 interventional studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

Abbott is the lead sponsor of 361 studies on the registry; 1 is open to participants now.

Browse Abbott studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
100 participants (actual)

Study arms

  • Active comparator
    1

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

    Drug: Lopinavir/Ritonavir · Drug: Lamivudine · Drug: Stavudine

  • Active comparator
    2

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

    Drug: Lopinavir/Ritonavir · Drug: Lamivudine · Drug: Stavudine

Interventions

  • DrugLopinavir/Ritonavir

    Lopinavir, range from 200 mg to 400 mg, every 12 hrs and Ritonavir, range from 100 mg to 200 mg, every 12 hrs

    Also known as: ABT-387, Kaletra

  • DrugLamivudine

    150 mg, every 12 hours

  • DrugStavudine

    40 mg every 12 hours

06

What researchers measure

Primary outcomes

  1. Proportion of subjects with viral load below the limit of quantitation

    Time frame: 24 weeks

  2. Time to loss of virologic response

    Time frame: 48 weeks

Secondary outcomes

  1. Proportion of subjects with viral load below the limit of quantitation at each visit

    Time frame: At each visit

07

Study locations

10 sites
  • Pacific Oaks Research
    Beverly Hills, California 90211, United States
  • University of Colorado Health Sciences Center
    Denver, Colorado 80262, United States
  • AIDS Research Consortium of Atlanta
    Atlanta, Georgia 30308, United States
  • Northwestern University Medical School
    Chicago, Illinois 60611, United States
  • Rush-Presbyterian-St. Luke's Medical Center
    Chicago, Illinois 60612, United States
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts 02215, United States
  • Cornell Clinical Trials Unit - Chelsea Center
    New York, New York 10011, United States
  • University of North Carolina at Chapel Hill
    Chapel Hill, North Carolina 27516, United States
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
  • Baylor College of Medicine
    Houston, Texas 77030, United States
08

References and documents

Publications

  • 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)
  • 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. PubMed 11192874 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 1997, a primary completion of Apr 2005 and a completion of Apr 2005. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 2, 1999
First posted
Aug 31, 2001
Start
Nov 1997
Primary completionActual
Apr 2005
CompletionActual
Apr 2005
Last update
Apr 3, 2008
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 3, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00004578
Lead sponsor
Abbott
First posted
Aug 31, 2001
Start date
Nov 1997
Primary completion
Apr 2005
Completion
Apr 2005
Last update
Apr 3, 2008

Study contacts

George Hanna, MD
study director · Abbott

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2008. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

HIV Infections →

Other studies from this sponsor

Abbott →

Start the discussion