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

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Collaborator: Bristol-Myers Squibb
• Treatments: Atazanavir Sulfate; Ritonavir

Criteria

Inclusion Criteria:

Stable primary care

1. Male or Female HIV + adults > 18 years of age.

2. Subjects who are receiving a ritonavir-boosted PI-containing regimen.

3. Subjects who are on a stable antiretroviral regimen for > 3 months.

4. Subjects who have a plasma viral load > 1,000 and < 100,000 c/mL.

5. 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).

6. Subjects who have a CD4 > 100 cells/cc.

7. Subjects who are experiencing hyperlipidemia :

8. Total cholesterol > 240 mg/dL, or

9. LDL > 160 mg/dL, or

10. Fasting triglycerides > 200 mg/dL, or

11. On lipid lowering drugs.

12. 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:

13. Written or oral documentation communicated by clinician or clinician's staff of one of the following:

1. Physician report/letter

2. Operative report or other source documentation in the patient record

3. Discharge summary

4. Laboratory report of azoospermia (required for acceptable documentation of successful vasectomy)

5. FSH measurement elevated into the menopausal range as established by the reporting laboratory. Exclusion Criteria:1. 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

1. Symptomatic heart block

2. 3rd degree heart block, even if asymptomatic

3. Pre-excitation syndromes

4. Heart rate < 40 bpm

5. Ventricular pause length > 3 sec

6. QTc > 500 msec

7. History of syncope of undetermined origin

8. Cardiomyopathy