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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/NCT00028301




Registration number
NCT00028301
Ethics application status
Date submitted
20/12/2001
Date registered
21/12/2001
Date last updated
13/09/2010

Titles & IDs
Public title
Atazanavir Versus Lopinavir/Ritonavir (LPV/RTV) in Patients Who Have Not Had Success With Protease Inhibitor-Containing HAART Regimen(s)
Scientific title
A Randomized Open-label Study of the Antiviral Efficacy and Safety of Atazanavir Versus Lopinavir/Ritonavir(LPV/RTV), Each in Combination With Two Nucleosides in Subjects Who Have Experienced Virologic Failure With Prior Protease Inhibitor-Containing HAART Regimen(s)
Secondary ID [1] 0 0
AI424-043
Secondary ID [2] 0 0
302D
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 - Atazanavir
Treatment: Drugs - Lopinavir/Ritonavir

Treatment: Drugs: Atazanavir


Treatment: Drugs: Lopinavir/Ritonavir
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 receiving a PI-containing highly active antiretroviral therapy (HAART) for at
least 12 weeks.

- Have a viral load of 1,000 or more copies/ml within 4 weeks of screening and within 4
weeks prior to randomization.

- Have 2 CD4 cell counts of 50 or more cells/mm3 at least 96 hours apart and within 4
weeks before randomization.

- Are at least 16 years old.

- Have a documented virologic response to at least 1 HAART regimen.

- Have phenotypic sensitivity to at least 2 of the following: ddl, d4T, ZDV, 3TC, ABC.

- Have phenotypic sensitivity to atazanavir and LPV/RTV.

- Use effective barrier methods of birth control.

- Will be available for 48 weeks.
Minimum age
16 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 taken 2 or more PIs and had virologic failure.

- Have taken atazanavir or LPV/RTV.

- Have an HIV-related infection (within 30 days) or any medical condition requiring
treatment at the time of enrollment.

- Have had acute hepatitis in the 30 days prior to study entry.

- Have received certain drugs within 3 months of study start or expect to need them at
time of enrollment.

- Abuse alcohol or drugs in a way that would interfere with the study.

- Have very bad diarrhea within 30 days prior to study entry.

- Are pregnant or breast-feeding.

- Have a history of hemophilia.

- Use lipid-lowering drugs (within the previous 30 days).

- Have cardiomyopathy or symptoms of other heart disease.

- Cannot take medicine by mouth.

- Have any other condition that would interfere with the study.

- Have pancreatitis, if choosing ddI as part of NRTI pair.

- Have bilateral peripheral neuropathy at time of screening, if choosing ddI or or d4T
as part of the NRTI pair.

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
Open (masking not 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
1/02/2001
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2003
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Alfred Hosp - Prahan
Recruitment hospital [2] 0 0
Prahran Market Clinic - South Yarra
Recruitment hospital [3] 0 0
Saint Vincent's Hosp Med Centre - Sydney
Recruitment hospital [4] 0 0
Taylors Square Clinic - Sydney
Recruitment postcode(s) [1] 0 0
- Prahan
Recruitment postcode(s) [2] 0 0
- South Yarra
Recruitment postcode(s) [3] 0 0
- Sydney
Recruitment outside Australia
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Alabama
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Milano
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Rimini
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Roma
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Torino
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Mexico City
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Netherlands
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CX Utrecht
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Lima
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Sevilla
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Birmingham
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Liverpool
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will compare 2 treatments in the way they affect cholesterol levels and the amount
of HIV in the blood.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00028301
Trial related presentations / publications
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/NCT00028301