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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00004583




Registration number
NCT00004583
Ethics application status
Date submitted
2/11/1999
Date registered
31/08/2001
Date last updated
20/02/2009

Titles & IDs
Public title
A Phase III Study Comparing Two Different Anti-HIV Drug Combinations in HIV-Positive Patients Without Previous Anti-HIV Drug Therapy
Scientific title
A Randomized, Double-Blind, Phase III Study of ABT-378/Ritonavir Plus Stavudine and Lamivudine vs Nelfinavir Plus Stavudine and Lamivudine in Antiretroviral Naive HIV-Infected Subjects
Secondary ID [1] 0 0
M98-863
Secondary ID [2] 0 0
285C
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Lopinavir/Ritonavir
Treatment: Drugs - Nelfinavir mesylate
Treatment: Drugs - Lamivudine
Treatment: Drugs - Stavudine

Treatment: Drugs: Lopinavir/Ritonavir


Treatment: Drugs: Nelfinavir mesylate


Treatment: Drugs: Lamivudine


Treatment: Drugs: Stavudine
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
Inclusion Criteria

You may be eligible for this trial if you:

- Are HIV positive.

- Have a viral load (level of HIV in your blood) of more than 400 copies/ml.

- Are age 12 or older.

- Agree to practice abstinence or use effective methods of birth control during the
study.
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

You will not be eligible for this trial if you:

- Have taken anti-HIV drugs for more than 14 days in the past, or if you have ever taken
d4T or 3TC.

- Are seriously ill or have an AIDS-related infection.

- Are pregnant or breast-feeding.

- Are taking certain medications.

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/1999
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Brisbane Hosp - Herston
Recruitment hospital [2] 0 0
Royal Perth Hosp - Perth
Recruitment hospital [3] 0 0
Alfred Hosp - Prahan
Recruitment postcode(s) [1] 0 0
- Herston
Recruitment postcode(s) [2] 0 0
- Perth
Recruitment postcode(s) [3] 0 0
- Prahan
Recruitment outside Australia
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California
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Connecticut
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Florida
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Georgia
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Illinois
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Indiana
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Kansas
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Louisiana
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Massachusetts
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Michigan
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New York
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North Carolina
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Ohio
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Texas
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Virginia
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Wisconsin
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Austria
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Wien
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Brazil
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Manguinhos RJ
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Brazil
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Sao Paulo
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Canada
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British Columbia
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Canada
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Ontario
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Canada
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Quebec
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Denmark
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Copenhagen
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Denmark
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Hvidovre
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France
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Compiegne
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France
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Paris Cedex 18
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France
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Paris
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France
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Villejuif
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Germany
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Berlin
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Germany
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Dusseldorf
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Germany
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Frankfurt
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Germany
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Hamburg
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Germany
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Koeln
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Poland
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Warszawa
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Puerto Rico
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San Juan
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South Africa
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Belford Gardens
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South Africa
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Johannesburg
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South Africa
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Parktown
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Spain
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Barcelona
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Madrid
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Spain
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Sevilla
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Switzerland
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Zurich
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Brighton
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United Kingdom
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London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Abbott
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to see how safe a new protease inhibitor (PI) is and how well it
fights HIV infection. A PI is a drug that stops HIV from using healthy cells to make more
virus. This study will compare the new PI combination of ABT-378 plus ritonavir (RTV) with
another PI, nelfinavir (NFV).

Earlier studies suggest ABT-378/RTV will be just as good as and perhaps better than NFV at
fighting HIV infection.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00004583
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
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Address 0 0
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Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
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Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00004583