ClinicalTrials.Veeva

Menu

NRTI-Sparing Pilot Study

University of British Columbia logo

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)

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

Trial contacts and locations

4

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems