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Completed

NCT Number: NCT00143689

NRTI-Sparing Pilot Study

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.

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Key information

Conditions

HIV Mitochondrial Toxicity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

McMaster University, Hamilton, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lopinavir/ritonavir; nevirapine; Zidovudine; Lamivudine

Drug

See Detailed Description.

Primary outcomes

  1. Changes in mitochondrial DNA/Nuclear DNA (mtDNA/nDNA) ratio at 48 weeks, as a marker of mitochondrial toxicity.

    Time frame: 48 weeks

Secondary outcomes

  1. Changes in mitochondrial DNA/Nuclear DNA (mtDNA/nDNA) ratio at 96 weeks

    Time frame: 96 weeks

  2. Proportions of patients with viral load below 50 and below 400 copies/mL

  3. Viral load changes from baseline

  4. Rates and extent of immune reconstitution (CD4 count increase)

  5. Rates and severity of dyslipidemia and insuline resistance/diabetes

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Abbott
  • Boehringer Ingelheim
  • CIHR Canadian HIV Trials Network

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2008
Study completion
2008
First posted
Sep 2, 2005
Registry last updated
Sep 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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