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

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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00120393

Enrollment

192

Registered

2005-07-18

Start date

2004-01-31

Completion date

2006-05-31

Last updated

2010-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

Treatment Experienced

Brief summary

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).

Interventions

DRUGatazanavir/ritonavir +2 NRTIs (immediate Switch Group)

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

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

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Mean change in cholesterol measures at Weeks 12, 24 and 48.	—
Mean percent changes from baseline in fasting glucose and insulin at Weeks 12, 24 and 48.	—
The proportion of subjects receiving lipid lowering therapy at Weeks 24 and 48.	—
Mean percent change in fasting non-HDL cholesterol at Weeks 24 and 48.	—
The proportion of subjects with non-HDL cholesterol less than 160mg/dL at Weeks 12, 24 and 48.	—
The frequency and severity of all clinical and laboratory AEs and discontinue for AEs.	—
The proportion of subjects with LDL cholesterol less than 130mg/dL at Weeks 12, 24 and 48.	—

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026