Atazanavir or Boosted Atazanavir Substitution for Ritonavir Boosted PI in Patients With Hyperlipidemia

NCT00160329 | Completed Phase 3 DMC

• 3 other identifiers: De-Escalate TrialIRB # 79603Spo# 29750
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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, or Switching to Atazanavir in combination to Ritonavir.

Conditions

Hyperlipidemia; HIV Infections

Outcome Measures

Primary Outcomes (1)

• Compare the three arms (ATV, ATV/r and continued ritonavir boosted-PI) in the following primary endpoint: % subjects who have normal serum lipid profile off lipid lowering agents and maintain CD4 counts > 75% of baseline line values.

  48 weeks

Secondary Outcomes (7)

• % subjects with serum lipids within normal limits at week 48 off of any lipid lowering agent.

  48 weeks

• % subjects who maintain CD4 counts > 75% of baseline values at week 48.

  48 weeks

• Compare the change in CD4 count and CD4 % at 24 and 48 weeks between the three study arms.1.2.4Compare HIV plasma viral load profile over 24 and 48 weeks as DAVG between the three study arms.

  24 and 48 weeks

• Compare lipid profile over 48 weeks, change in total cholesterol, TC/HDL ratio and triglycerides.

  48 weeks

• Compare the evolution of genotypic and phenotypic drug resistance over 12 and 48 weeks between the three arms.

  12 and 48 weeks

Interventions

Atazanavir DRUG

300 mg with ritonavir boosting or 400 mg without

Also known as: Reyataz

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• \. 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.
• \. Subjects who have significant liver disease defined as AST (SGOT) and ALT (SGPT) \> 5 x ULN.
• \. Subjects who have a history of an acute opportunistic infection within 8 weeks prior to study screening. Chronic infections will not be excluded.
• \. Subjects who have received a vaccination within 2 weeks prior to study screening.
• \. Subjects who are receiving experimental ARV therapy.
• \. Subjects who are receiving systemic chemotherapy.
• \. Subjects who are receiving IL-2 or IFN-alpha.
• \. Subjects who are receiving GM-CSF.
• \. Subjects who have any grade 3-4 laboratory abnormality or clinical AE, other than lipid abnormalities.
• \. Prior use of Atazanavir
• \. Subjects who have a history of
• Symptomatic heart block
• rd degree heart block, even if asymptomatic
• Pre-excitation syndromes
• Heart rate \< 40 bpm

Sponsors & Collaborators

• Stanford University: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Hyperlipidemias; HIV Infections

Interventions

Atazanavir Sulfate

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Andrew R Zolopa

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: January 1, 2004
• Primary Completion: April 1, 2007
• Study Completion: March 1, 2009
• Last Updated: July 21, 2011

Record last verified: 2011-07

Locations

US (1)