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.

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