NRTI-Sparing Pilot Study

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of British Columbia
• Collaborators: Abbott; Boehringer Ingelheim; CIHR Canadian HIV Trials Network
• Treatments: Lamivudine; Lopinavir; Nevirapine; Reverse Transcriptase Inhibitors; Ritonavir; Zidovudine

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