Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
13 participants
INTERVENTIONAL
2002-04-30
2008-02-29
Brief Summary
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Participants will be randomly assigned to receive one of the following drug combinations:
* lopinavir/ritonavir (Kaletra) and nevirapine (Viramune) twice a day;
* Combivir (Zidovudine (AZT) plus lamivudine (3TC)) and nevirapine twice a day;
* Combivir and lopinavir/ritonavir twice a day.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Lopinavir/ritonavir, Zidovudine, Lamivudine
Participants will be randomly assigned to receive one of the following drug combinations:
* lopinavir/ritonavir (Kaletra) and nevirapine (Viramune) twice a day;
* Combivir (Zidovudine (AZT) plus lamivudine (3TC)) and nevirapine twice a day;
* Combivir and lopinavir/ritonavir twice a day.
lopinavir/ritonavir; nevirapine; Zidovudine; Lamivudine
See Detailed Description.
Interventions
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lopinavir/ritonavir; nevirapine; Zidovudine; Lamivudine
See Detailed Description.
Eligibility Criteria
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Inclusion Criteria
* Be at least18 years of age
* Have viral load above 5 000 copies/ml
* Be likely to comply with the study protocol
* Agree not to take, for the duration of the study, any drug that is contraindicated with the study drugs
* Agree not to take any medication, including over-the-counter medicine, alcohol, or street drugs without the knowledge and permission of the principal investigator
Exclusion Criteria
* Pregnancy or breastfeeding
* Have abnormal laboratory tests (see investigator)
* Have received an investigational drug within 30 days of study drugs administration
* Be receiving systemic chemotherapy
* Have an acute illness
18 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
Boehringer Ingelheim
INDUSTRY
CIHR Canadian HIV Trials Network
NETWORK
University of British Columbia
OTHER
Responsible Party
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Principal Investigators
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Julio Montaner, MD
Role: PRINCIPAL_INVESTIGATOR
University of British Columbia/Providence Health Care
Locations
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McMaster University
Hamilton, Ontario, Canada
University of Ottawa Health Services
Ottawa, Ontario, Canada
Maple Leaf Clinic
Toronto, Ontario, Canada
Clinique Medicale L'Actuel
Montreal, Quebec, Canada
Countries
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Other Identifiers
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CTN 177
Identifier Type: -
Identifier Source: secondary_id
H02-50066
Identifier Type: -
Identifier Source: org_study_id
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