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OpenTrials
Completed

NCT Number: NCT00120393

Study of HIV Patients With Undetectable Viral Load and Abnormal Lipids Switching to Atazanavir/Ritonavir

Patients with HIV who are virologically suppressed on a lopinavir/ritonavir combination highly active antiretroviral therapy (HAART) regimen but with elevated non-HDL cholesterol are randomized to remain on lopinavir/ritonavir or change to atazanavir/ritonavir in combination with current nucleoside reverse transcriptase inhibitors (NRTIs).

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Local Institution, Hamilton, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • HIV positive
  • LPV/RTV-based HAART for at least 6 months
  • HIV-1 RNA less than 50c/mL (confirmed)
  • Non-HDL higher than 160 mg/dL
  • CD4 of at least 50 cells/mL

Exclusion criteria

  • Use of lipid-lowering agents

Treatment and study plan

atazanavir/ritonavir +2 NRTIs (immediate Switch Group)

Drug

Capsules, Oral, ATV 300mg/RTV 100mg + 2 NRTIs, QD, 48 weeks.

Other names: Reyataz

LPV/r +2 NRTIs (Delayed/optional Switch Group)

Drug

Capsules, Oral, LPV 400mg/RTV 100mg +2 NRTIs, BID, 24 weeks then option to switch to ATV arm or stay until 48 weeks.

Primary outcomes

  1. To compare the Week 12 percent change from baseline in fasting non-HDL cholesterol between subjects who are switched to an ATV/RTV-containing regimen and those who continue on a LPV/RTV based regimen.

Secondary outcomes

  1. Mean percent change in fasting non-HDL cholesterol at Weeks 24 and 48.

  2. Mean change in cholesterol measures at Weeks 12, 24 and 48.

  3. Mean percent changes from baseline in fasting glucose and insulin at Weeks 12, 24 and 48.

  4. The proportion of subjects receiving lipid lowering therapy at Weeks 24 and 48.

  5. The proportion of subjects with LDL cholesterol less than 130mg/dL at Weeks 12, 24 and 48.

  6. The proportion of subjects with non-HDL cholesterol less than 160mg/dL at Weeks 12, 24 and 48.

  7. The frequency and severity of all clinical and laboratory AEs and discontinue for AEs.

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase IIIB, Open-label, Randomized, Multi-center Study Evaluating the Effect on Serum Lipids Following a Switch to ATV/r in HIV-1 Infected Subjects Who Have Achieved Virologic Suppression on a LPV/r Based Regimen.

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Jul 18, 2005
Registry last updated
Feb 5, 2010

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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