Equivalence of Boosted Atazanavir Based Regimens and Currently Effective HAART Regimens

NCT00940771 | Completed Phase 4 Results

• 1 other identifier: PCH 09-004
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The hypothesis for this study is whether a treatment regimen containing Atazanavir in combination with Ritonavir will work as well as other regimens containing a protease inhibitor and/or a Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) at controlling HIV disease in children who are HIV+ and have high cholesterol or high triglycerides. . In this study, children who have high cholesterol or high triglycerides as a result of their HIV medicines, will have the PI or NNRTI in their medication regimen changed to Atazanavir, which is a PI in combination with a low dose of Ritonavir (another PI). Atazanavir has been shown in adults to result in lower cholesterol and triglycerides than other PI's and NNRTI's. The dose of Atazanavir and Ritonavir will be according to the Package Insert for this drug that is FDA approved for children. They will continue taking the other medications from the pre-study regimen. Children will take study drug for 24 weeks, and will be able to continue study drug after the study using commercially available drug. Lab tests and a physical exam will be undertaken at 4 weeks, 12 weeks and 24 weeks after starting study drug to determine how effective the new drug is and to monitor for possible side effects.

Conditions

Pediatric HIV; HIV Infections

Keywords

HIV; Lipids; Atazanavir; Pediatric; treatment experienced

Outcome Measures

Primary Outcomes (2)

• Non-fasting Cholesterol

  4 Weeks, 12 weeks, 24 weeks

• Non-fasting Triglycerides

  4 weeks, 12 weeks, 24 weeks

Secondary Outcomes (2)

• Viral Load

  4 weeks, 12 weeks, 24 weeks

• CD4 Count

  4 Weeks, 12 weeks, 24 weeks

Study Arms (1)

boosted Atazanavir

EXPERIMENTAL

Boosted Atazanavir was switched for the PI or NNRTI in the patients regimen

Drug: Boosted Atazanavir

Interventions

Boosted Atazanavir DRUG

Boosted Atazanavir, once a day dose adjusted for child's weight for 6 months.

Also known as: Reyataz

boosted Atazanavir

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• HIV positive children with elevated lipid levels
• on stable HAART for at least 3 months (defined to be on the same regimen with viral load \< 1000 for 6 months prior to baseline visit).
• Weight equal to or greater than 25kg
• Able to swallow pills or willing to learn

You may not qualify if:

• Patients with underlying hepatitis B or C viral infections
• Previously demonstrated clinically significant hypersensitivity (eg, Stevens-Johnson syndrome, erythema multiforme, or toxic skin eruptions) to any of the components of Reyataz® (atazanavir).
• Taking other medications that are highly dependent on CYP3A or UGT1A1 for clearance
• Ergot medicines: dihydroergotamine, ergonovine, ergotamine, and methylergonovine such as Cafergot®, Migranal®, D.H.E. 45®, ergotrate maleate, Methergine®, and others (used for migraine headaches).
• Orap® (pimozide, used for Tourette's disorder).
• Propulsid® (cisapride, used for certain stomach problems).
• Triazolam, also known as Halcion® (used for insomnia).
• Midazolam, also known as Versed® (used for sedation), when taken by mouth.
• Camptosar® (irinotecan, used for cancer).
• Crixivan® (indinavir, used for HIV infection).
• Cholesterol-lowering medicines Mevacor® (lovastatin) or Zocor® (simvastatin).
• Rifampin (also known as Rimactane®, Rifadin®, Rifater®, or Rifamate®).
• St. John's wort (Hypericum perforatum), an herbal product sold as a dietary supplement,
• Viramune® (nevirapine, used for HIV infection).
• Vfend® (voriconazole).

Sponsors & Collaborators

• Phoenix Children's Hospital: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Atazanavir Sulfate

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Small sample size Non fasting lipid levels Large variety of prior treatment regimens

Results Point of Contact

• Title: Janice Piatt, MD, Medical Director
• Organization: Bill Holt Clinic, Phoenix Children's Hospital

jpiatt@phoenixchildrens.com

602-933-0955

Study Officials

• Janice Piatt, MD

  Phoenix Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director, Bill Holt Clinic

Study Record Dates

• First Submitted: July 15, 2009
• First Posted: July 16, 2009
• Study Start: August 26, 2009
• Primary Completion: October 16, 2013
• Study Completion: November 23, 2016
• Last Updated: April 20, 2020
• Results First Posted: April 20, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)