Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

NRTI-Sparing Pilot Study

This study has been completed.
Sponsor:
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
History of Changes
  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:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in mitochondrial DNA/Nuclear DNA (mtDNA/nDNA) ratio at 96 weeks [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
  • Proportions of patients with viral load below 50 and below 400 copies/mL [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
  • Viral load changes from baseline [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
  • Rates and extent of immune reconstitution (CD4 count increase) [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
  • Rates and severity of dyslipidemia and insuline resistance/diabetes [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
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:

  • 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.
 Drug: lopinavir/ritonavir; nevirapine; Zidovudine; Lamivudine
See Detailed Description.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

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

No publications provided

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
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Lamivudine
Lopinavir
Ritonavir
Zidovudine
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antimetabolites
Antiviral Agents
 Enzyme Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Protease Inhibitors
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on March 02, 2015