Lopinavir/r or Fosamprenavir/r Switch to Atazanavir/r or Darunavir/r

NCT00756730 | Completed Phase 4 Results

• 1 other identifier: 08-09
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 11

Brief Summary

For participants with HIV taking either lopinavir or fosamprenavir who have elevated triglycerides, this trial will study the change in triglycerides after switching protease inhibitors.

Conditions

HIV Infections

Keywords

lopinavir; ritonavir; atazanavir; fosamprenavir; darunavir; anti-retroviral; AIDS; HIV; LARD; triglyceride; protease inhibitors; treatment Experienced

Outcome Measures

Primary Outcomes (3)

• Percentage of Patients That Experience 10% Decline in Triglycerides From Baseline to Week 24.

  A 10% decline in triglycerides (TGs) was determined to be clinically significant. The percentage of people that experienced a 10% decline was calculated by dividing the number who had a decline of 10% TGs by the total number of participants in the arm.

  baseline, 24 weeks

• At Week 24 the Percentage of Subjects That Had Triglycerides Less Than 200 mg/dL

  24 weeks

• The Change in Fasting Triglyceride Level From Baseline to Week 24

  Baseline to week 24

Secondary Outcomes (5)

• Percent of Patients With HIV VL <200 Copies/mL at Week 4, 12 & 24

  Week 4, 12 & 24

• Difference in CD4 From Baseline to Week 24

  baseline to Week 24

• Total Cholesterol in the Two Study Groups at 24 Weeks

  Week 24

• LDL Cholesterol at Week 24

  week 24

• HDL Cholesterol at Week 24

  24 weeks

Study Arms (2)

Switch to DRV/r (800mg/100mg) QD

OTHER

We designed a study to determine if switching virologically suppressed patients on a regimen containing LPV/r or FPV/r to either DRV/r or ATV/r would result in improved TGs while maintaining virological suppression. For this arm the sbject switched to DRV/r at a dose 800mg/100mg QD for 24 weeks. Subjects will continue to maintain their background NRTI drugs throughout the screening period and during the entire study.

Drug: DRV/r

Switch to ATV/r (300mg/100mg QD)

OTHER

We designed a study to determine if switching virologically suppressed patients on a regimen containing LPV/r or FPV/r to either DRV/r or ATV/r would result in improved TGs while maintaining virological suppression. For this are the subject switched to ATV/r at a dose of 300mg/100mg QD for 24 weeks. Subjects will continue to maintain their background NRTI drugs throughout the screening period and during the entire study

Drug: ATV/r

Interventions

ATV/r DRUG

Switch to ATV/r at a dose of 300mg/100mg QD for 24 weeks. Subjects will continue to maintain their background NRTI drugs throughout the screening period and during the entire study.

Also known as: Atazanavir/r

Switch to ATV/r (300mg/100mg QD)

DRV/r DRUG

We designed a study to determine if switching virologically suppressed patients on a regimen containing LPV/r or FPV/r to either DRV/r or ATV/r would result in improved TGs while maintaining virological suppression. Switch to DRV/r at a dose 800mg/100mg QD for 24 weeks. Subjects will continue to maintain their background NRTI drugs throughout the screening period and during the entire study.

Switch to DRV/r (800mg/100mg) QD

Eligibility Criteria

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

You may qualify if:

• Currently receiving Antiretroviral Therapy (ART) regimen including LPV/r or FPV/r and \> or equal to 2 Nucleoside Reverse Transcriptase Inhibitors (NRTIs). Patient must be on a stable regimen containing LPV/r or FPV/r for at least 12 weeks prior to screening.
• Documentation of an undetectable Human Immunodeficiency Virus (HIV) viral load (VL\<400 copies/ml) using an FDA approved assay for a minimum of twelve weeks prior to screening AND undetectable HIV viral load using an FDA approved ultrasensitive assay at screening.
• No evidence of HIV protease resistance as defined by the Stanford HIV database
• Currently receiving first protease inhibitor unless switch to LPV/r or FPV/r was for non-virologic reasons
• Fasting triglycerides \> 200 mg/dL
• No ongoing issues that in the opinion of the investigator would lead to decreased ability to comply with the study procedures
• If currently receiving a proton pump inhibitor, the dose is \< omeprazole 20 mg or the equivalent dose of another proton pump inhibitor
• If patient is receiving another lipid lowering medication, it must be at a stable dose

You may not qualify if:

• Currently receiving an ART regimen other than \> or equal to two NRTIs and either LPV/r or FPV/r
• Prior use of darunavir or atazanavir
• CDC Class C Illness diagnosed within 30 days of screening
• Patient is currently receiving the following Hydroxamethylglutaryl-coA (HMGCoA) reductase inhibitor medications (statins): pravastatin, lovastatin, simvastatin
• Patient is currently receiving a bile acid sequestrant (cholestyramine, colestipol, and colesevelam)
• Grade 3 or 4 Laboratory abnormalities as defined by a standardized grading scheme based on the DAIDS table with the following exceptions:
• Pre-existing diabetes mellitus with asymptomatic, nonfasting glucose grade 3 elevations
• Subjects with asymptomatic grade 3 fasting triglyceride or cholesterol elevations
• Clinical or laboratory evidence of clinically significant liver impairment/dysfunction disease or cirrhosis
• Note: Individuals co-infected with chronic hepatitis B or C viruses will be allowed to enter the trial if their condition is clinically stable and they will not require therapy during the course of the study. Individuals diagnosed with acute viral hepatitis at screening will not be allowed to enroll during acute phase
• Active substance abuse or significant psychiatric illness that in the opinion of the investigator might interfere with study compliance
• Use of any investigational agents 30 days prior to screening
• Life expectancy \< 6 months in the opinion of the investigator
• Pregnancy or breast feeding
• Female subject of childbearing potential (i.e., heterosexually active, and not surgically sterile or at least two years post-menopausal) not using effective non-hormonal birth control methods or not willing to continue practicing these birth control methods from screening until the last trial related activity

Sponsors & Collaborators

• Community Research Initiative of New England: lead
• Tibotec Pharmaceutical Limited: collaborator

Study Sites (11)

Spectrum Medical Group

Phoenix, Arizona, 85012, United States

Location

AIDS Healthcare Foundation

Los Angeles, California, 02319, United States

Location

Orlando Immunology Center

Orlando, Florida, 32803, United States

Location

Community Research Initiative

Boston, Massachusetts, 02215, United States

Location

Community Research Initiative - West

Springfield, Massachusetts, 01107, United States

Location

Abbott Northwestern Infectious Disease and Travel Clinic

Minneapolis, Minnesota, 55404, United States

Location

AIDS Community Health Center

Rochester, New York, 14804, United States

Location

Philadelphia Fight

Philadelphia, Pennsylvania, 19107, United States

Location

David M. Lee, M.D., P.A., a/b/a Uptown Physicians Group

Dallas, Texas, 75204, United States

Location

Nicholaos C. Bellos, MD, PA

Dallas, Texas, 75204, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

atazanavir, ritonavir drug combination

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; Slow Virus Diseases

Results Point of Contact

• Title: Dr. Daniel Skiest
• Organization: Community Research initiavte

Daniel.Skiest@baystatehealth.org

413 794 5376

Study Officials

• Daniel J Skiest, MD

  Community Research Initiative

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2008
• First Posted: September 22, 2008
• Study Start: September 1, 2008
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: August 21, 2017
• Results First Posted: July 13, 2012

Record last verified: 2017-07

Locations

US (11)