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NRTI-Sparing Pilot Study
This study has been completed.
Sponsor:
University of British Columbia
Collaborators:
Abbott
Boehringer Ingelheim
CIHR Canadian HIV Trials Network
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00143689
First received: August 31, 2005
Last updated: September 25, 2014
Last verified: September 2014
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Purpose
This study will compare a nucleoside reverse transcriptase inhibitor-sparing (NRTI-sparing) regimen (Kaletra + nevirapine) to two nucleoside reverse transcriptase inhibitor-based regimens (Combivir + nevirapine and Combivir + Kaletra).
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.
| Condition | Intervention | Phase |
|---|---|---|
| HIV Mitochondrial Toxicity | Drug: lopinavir/ritonavir; nevirapine; Zidovudine; Lamivudine | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Pilot Study of a Nucleoside Analogue Reverse Transcriptase Inhibitor Sparing Regimen in Antiretroviral-Naïve, HIV-infected Patients |
Resource links provided by NLM:
Further study details as provided by University of British Columbia:
Primary Outcome Measures:
- Changes in mitochondrial DNA/Nuclear DNA (mtDNA/nDNA) ratio at 48 weeks, as a marker of mitochondrial toxicity. [ Time Frame: 48 weeks ]
Secondary Outcome Measures:
- Changes in mitochondrial DNA/Nuclear DNA (mtDNA/nDNA) ratio at 96 weeks [ Time Frame: 96 weeks ]
- Proportions of patients with viral load below 50 and below 400 copies/mL [ Time Frame: Unspecified ]
- Viral load changes from baseline [ Time Frame: Unspecified ]
- Rates and extent of immune reconstitution (CD4 count increase) [ Time Frame: Unspecified ]
- Rates and severity of dyslipidemia and insuline resistance/diabetes [ Time Frame: Unspecified ]
| Enrollment: | 13 |
| Study Start Date: | April 2002 |
| Study Completion Date: | February 2008 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Lopinavir/ritonavir, Zidovudine, Lamivudine
Participants will be randomly assigned to receive one of the following drug combinations:
|
Drug: lopinavir/ritonavir; nevirapine; Zidovudine; Lamivudine
See Detailed Description.
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Be HIV-positive
- 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:
- Have ever received antiretroviral therapy
- 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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00143689
Please refer to this study by its ClinicalTrials.gov identifier: NCT00143689
Locations
| Canada, Ontario | |
| McMaster University | |
| Hamilton, Ontario, Canada | |
| University of Ottawa Health Services | |
| Ottawa, Ontario, Canada | |
| Maple Leaf Clinic | |
| Toronto, Ontario, Canada | |
| Canada, Quebec | |
| Clinique Medicale L'Actuel | |
| Montreal, Quebec, Canada | |
Sponsors and Collaborators
University of British Columbia
Abbott
Boehringer Ingelheim
CIHR Canadian HIV Trials Network
Investigators
| Principal Investigator: | Julio Montaner, MD | University of British Columbia/Providence Health Care |
More Information
| Responsible Party: | University of British Columbia |
| ClinicalTrials.gov Identifier: | NCT00143689 History of Changes |
| Other Study ID Numbers: |
H02-50066 CTN 177 |
| Study First Received: | August 31, 2005 |
| Last Updated: | September 25, 2014 |
Additional relevant MeSH terms:
|
Ritonavir Lopinavir Lamivudine Zidovudine Nevirapine Reverse Transcriptase Inhibitors HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Nucleic Acid Synthesis Inhibitors Antimetabolites Cytochrome P-450 CYP3A Inducers Cytochrome P-450 Enzyme Inducers |
ClinicalTrials.gov processed this record on July 21, 2017