NRTI-Sparing Pilot Study

University of British Columbia

Status and phase: Completed; Phase 4

Conditions: HIV; Mitochondrial Toxicity

Treatments: Drug: lopinavir/ritonavir; nevirapine; Zidovudine; Lamivudine

Study type: Interventional

Funder types: Other; NETWORK; Industry

Identifiers

NCT00143689

CTN 177

H02-50066

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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13 participants in 1 patient group

Lopinavir/ritonavir, Zidovudine, Lamivudine

Experimental group

Description:

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.

Treatment:

Drug: lopinavir/ritonavir; nevirapine; Zidovudine; Lamivudine