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

August 31, 2005
September 25, 2014
April 2002
February 2008   (final data collection date for primary outcome measure)
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 ]
Changes in mitochondrial DNA/Nuclear DNA (mtDNA/nDNA) ratio at 48 weeks, as a marker of mitochondrial toxicity.
Complete list of historical versions of study NCT00143689 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Changes in mitochondrial DNA/Nuclear DNA (mtDNA/nDNA) ratio at 96 weeks
  • Proportions of patients with viral load below 50 and below 400 copies/mL
  • Viral load changes from baseline
  • Rates and extent of immune reconstitution (CD4 count increase)
  • Rates and severity of dyslipidemia and insuline resistance/diabetes
Not Provided
Not Provided
 
NRTI-Sparing Pilot Study
A Pilot Study of a Nucleoside Analogue Reverse Transcriptase Inhibitor Sparing Regimen in Antiretroviral-Naïve, HIV-infected Patients

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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV
  • Mitochondrial Toxicity
Drug: lopinavir/ritonavir; nevirapine; Zidovudine; Lamivudine
See Detailed Description.
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.
Intervention: Drug: lopinavir/ritonavir; nevirapine; Zidovudine; Lamivudine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
February 2008
February 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00143689
H02-50066, CTN 177
Not Provided
University of British Columbia
University of British Columbia
  • Abbott
  • Boehringer Ingelheim
  • CIHR Canadian HIV Trials Network
Principal Investigator: Julio Montaner, MD University of British Columbia/Providence Health Care
University of British Columbia
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP