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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/NCT00004581




Registration number
NCT00004581
Ethics application status
Date submitted
2/11/1999
Date registered
31/08/2001
Date last updated
20/02/2009

Titles & IDs
Public title
A Study to Compare Two Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Previously Received Anti-HIV Treatment
Scientific title
A Randomized, Open-Label, Phase III Study of ABT-378/Ritonavir in Combination With Nevirapine and Two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) vs. Investigator Selected Protease Inhibitor(s) in Combination With Nevirapine and Two NRTIs in Antiretroviral-Experienced HIV-Infected Subjects
Secondary ID [1] 0 0
M98-888
Secondary ID [2] 0 0
285D
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 - Nevirapine

Treatment: Drugs: Lopinavir/Ritonavir


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

Outcomes

Eligibility
Key inclusion criteria
Inclusion Criteria

Patients may be eligible for this study if they:

- Are at least 12 years old.

- Are HIV-positive and have a viral load (level of HIV in the blood) of 1,000 - 100,000
copies/ml.

- Are currently taking an anti-HIV drug combination that includes 1 PI and 2 NRTIs, and
that has not been changed in at least 12 weeks.

- Are naive to (have never taken) at least 1 NRTI, other than zalcitabine or abacavir.

- Agree to abstinence or use of an effective barrier method (e.g., condom) of birth
control.
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

Patients will not be eligible for this study if they:

- Have an active illness.

- Have received treatment for any active opportunistic (AIDS-related) infection within
30 days of study entry.

- Have ever received a nonnucleoside reverse transcriptase inhibitor (NNRTI).

- Have received investigational (not yet approved by the FDA) drugs within 30 days of
study entry.

- Have received treatment with a PI other than their current PI.

- Are receiving chemotherapy for cancer.

- Are pregnant or breast-feeding.

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
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 postcode(s) [1] 0 0
- Herston
Recruitment outside Australia
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Alabama
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Arizona
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California
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Connecticut
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Georgia
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Illinois
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Indiana
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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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Copenhagen
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Denmark
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Hvidovre
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Odense C
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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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Tourcoing
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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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Hamburg
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Koeln
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Germany
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Mannheim
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Ponce
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Belford Gardens
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South Africa
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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 compare the safety and effectiveness of 2 anti-HIV drug
combinations in HIV-infected patients. Both combinations will include nevirapine (NVP), 2
nucleoside reverse transcriptase inhibitors (NRTIs), and at least 1 protease inhibitor (PI).
One combination will include a new protease inhibitor, ABT-378, combined in a capsule with
ritonavir (RTV).
Trial website
https://clinicaltrials.gov/ct2/show/NCT00004581
Trial related presentations / publications
Public notes

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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00004581