Status:
COMPLETED
Atazanavir or Boosted Atazanavir Substitution for Ritonavir Boosted PI in Patients With Hyperlipidemia
Lead Sponsor:
Stanford University
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Hyperlipidemia
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The study is looking to compare the impact of lipid levels and HIV viral loads between three different drug regimens: Continuing current regimen (ritonavir boosted regimen), Switching to Atazanavir, o...
Detailed Description
Study Overview This is a randomized controlled pilot study to compare the safety and efficacy of substitution of atazanavir (ATV) or ATV/RTV for ritonavir boosted PI in patients with ongoing viremia ...
Eligibility Criteria
Inclusion
- Stable primary care
- Male or Female HIV + adults \> 18 years of age.
- Subjects who are receiving a ritonavir-boosted PI-containing regimen.
- Subjects who are on a stable antiretroviral regimen for \> 3 months.
- Subjects who have a plasma viral load \> 1,000 and \< 100,000 c/mL.
- Protease Inhibitor (PI) resistance: Subjects must have a minimum of 3 of the following PI-mutations (10, 20, 46, 47, 48, 50V, 54, 71, 82, 84, 90).
- Subjects who have a CD4 \> 100 cells/cc.
- Subjects who are experiencing hyperlipidemia :
- Total cholesterol \> 240 mg/dL, or
- LDL \> 160 mg/dL, or
- Fasting triglycerides \> 200 mg/dL, or
- On lipid lowering drugs.
- All women of reproductive potential (who have not reached menopause or undergone hysterectomy, bilateral oophorectomy, or tubal ligation) must have a negative serum or urine ²-HCG pregnancy test performed within 48 hours of entry.
- Female study volunteers who are not of reproductive potential (who have reached menopause or undergone hysterectomy, bilateral oophorectomy, or tubal ligation) or whose male partner has undergone successful vasectomy with documented azoospermia or has documented azoospermia for any other reason, are eligible without requiring the use of contraception. Acceptable documentation of menopause, sterilization, and azoospermia are as follows:
- Written or oral documentation communicated by clinician or clinician's staff of one of the following:
- Physician report/letter
- Operative report or other source documentation in the patient record
- Discharge summary
- Laboratory report of azoospermia (required for acceptable documentation of successful vasectomy)
- FSH measurement elevated into the menopausal range as established by the reporting laboratory.
Exclusion
- Women who are pregnant or breast feeding.
- 2\. Subjects who use substances or with a mental health condition that would in the opinion of the treating clinician interfere with the ability of the subject to comply with study treatment and monitoring.
- 3\. Subjects who have significant liver disease defined as AST (SGOT) and ALT (SGPT) \> 5 x ULN.
- 4\. Subjects who have a history of an acute opportunistic infection within 8 weeks prior to study screening. Chronic infections will not be excluded.
- 5\. Subjects who have received a vaccination within 2 weeks prior to study screening.
- 6\. Subjects who are receiving experimental ARV therapy.
- 7\. Subjects who are receiving systemic chemotherapy.
- 8\. Subjects who are receiving IL-2 or IFN-alpha.
- 9\. Subjects who are receiving GM-CSF.
- 10\. Subjects who have any grade 3-4 laboratory abnormality or clinical AE, other than lipid abnormalities.
- 11\. Prior use of Atazanavir
- 12\. Subjects who have a history of
- Symptomatic heart block
- 3rd degree heart block, even if asymptomatic
- Pre-excitation syndromes
- Heart rate \< 40 bpm
- Ventricular pause length \> 3 sec
- QTc \> 500 msec
- History of syncope of undetermined origin
- Cardiomyopathy
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00160329
Start Date
January 1 2004
End Date
March 1 2009
Last Update
July 21 2011
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305