NRTI-Sparing Pilot Study

HIV Clinical Trial

Official title:

A Pilot Study of a Nucleoside Analogue Reverse Transcriptase Inhibitor Sparing Regimen in Antiretroviral-Naïve, HIV-infected Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00143689
• Other study ID #: H02-50066
• Secondary ID: CTN 177
• Status: Completed
• Phase: Phase 4
• First received: August 31, 2005
• Last updated: September 25, 2014
• Start date: April 2002
• Est. completion date: February 2008

Study information

• Verified date: September 2014
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV
• Mitochondrial Toxicity

Intervention

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

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario
Canada	Clinique Medicale L'Actuel	Montreal	Quebec
Canada	University of Ottawa Health Services	Ottawa	Ontario
Canada	Maple Leaf Clinic	Toronto	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
University of British Columbia	Abbott, Boehringer Ingelheim, CIHR Canadian HIV Trials Network

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in mitochondrial DNA/Nuclear DNA (mtDNA/nDNA) ratio at 48 weeks, as a marker of mitochondrial toxicity.		48 weeks	No
Secondary	Changes in mitochondrial DNA/Nuclear DNA (mtDNA/nDNA) ratio at 96 weeks		96 weeks	No
Secondary	Proportions of patients with viral load below 50 and below 400 copies/mL		Unspecified	No
Secondary	Viral load changes from baseline		Unspecified	No
Secondary	Rates and extent of immune reconstitution (CD4 count increase)		Unspecified	No
Secondary	Rates and severity of dyslipidemia and insuline resistance/diabetes		Unspecified	No