Changes in Lipids and Safety of Raltegravir in HIV+ Patients With Hyperlipidemia While on Current Standard Therapy

NCT00887653 | Completed Phase 3 Results DMC

• 1 other identifier: 2007-09
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

The success of combination antiretroviral therapy heralded a revolution in the treatment of HIV in the mid-1990s. However, severe treatment-associated side effects have been observed including diabetes and increased cholesterol which are linked to premature heart attacks. This effect has been described among many regimens containing protease inhibitors (PIs), as well as non-nucleoside reverse transcriptase inhibitors (NNRTIs). Raltegravir is a new medicine which has been shown to be potent and efficacious in suppression of the HIV. This study hopes to determine if switching from a PI or NNRTI to raltegravir will decrease cholesterol in subjects with high cholesterol and well controlled HIV. In addition, the study aims to confirm that raltegravir is safe and well tolerated. It also seeks to confirm if raltegravir will have similar anti-HIV activity compared with the patient's previous regimen. The study will last 6 months and will involve 20 subjects. HIV-1 infected men and women on PIs or NNRTIs for at least 12 months before study entry with well controlled HIV will be recruited. Hypotheses:

1. 1.Patients with elevated lipid levels while on combination antiretroviral therapy with PIs or NNRTIs will experience an improvement in lipid levels after switching their PI or NNRTI to a raltegravir based regimen.
2. 2.Raltegravir will be safe and well tolerated.
3. 3.Raltegravir will have similar antiretroviral activity compared with the prior regimen.

Conditions

HIV; Hyperlipidemia; Hypertriglyceridemia; HIV Infections

Outcome Measures

Primary Outcomes (2)

• Change From Baseline Triglycerides

  Assess changes from baseline triglycerides at 3 months

  3 months

• Change From Baseline Triglycerides

  Assess changes from baseline triglycerides at 6 months

  6 months

Secondary Outcomes (1)

• Proportion of Patients With Plasma Viral Load Below the Limit of Detection

  6 months

Study Arms (1)

Raltegravir

EXPERIMENTAL

This is a single arm study where HIV-infected individuals virologically suppressed on current regimen will be switched to raltegravir +optimized back ground regimen for 6 months

Drug: raltegravir

Interventions

raltegravir DRUG

This will be a single arm study where subjects will be given the option to switch from their current regimen to raltegravir at 400mg twice daily.

Also known as: Isentress

Raltegravir

Eligibility Criteria

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

You may qualify if:

• Age \>18
• Fasting LDL\>130 mg/dL
• Fasting triglycerides \>250 mg/dL
• Plasma viral load below 50 copies/mL on current regimen for 6 months prior to study entry.
• No prior history of any NRTI resistance.

You may not qualify if:

• History of NRTI resistance mutations
• Need for medications that have drug interactions with raltegravir: dilantin, phenobarbitol and rifampin
• Unstable clinical condition, such as unstable cardiac disease, or cancer requiring ongoing chemotherapy or radiation therapy, or other medical condition which, in the opinion of the investigator, would preclude a subject from safely undergoing study procedures.
• Breast-feeding or pregnancy.
• Use of immunosuppressive medications within 60 days prior to study entry.
• Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.

Sponsors & Collaborators

• The Miriam Hospital: lead
• Tufts Medical Center: collaborator
• Merck Sharp & Dohme LLC: collaborator

Study Sites (2)

Tufts University

Boston, Massachusetts, 02111, United States

Location

Miriam Hospital Immunology Clinic

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

Hyperlipidemias; Hypertriglyceridemia; HIV Infections

Interventions

Raltegravir Potassium

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)

Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Aadia Rana
• Organization: THE MIRIAM HOSPITAL

arana@lifespan.org

4017934680

Study Officials

• Karen Tashima, MD

  The Miriam Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: April 23, 2009
• First Posted: April 24, 2009
• Study Start: May 1, 2009
• Primary Completion: June 1, 2012
• Study Completion: April 1, 2014
• Last Updated: October 10, 2014
• Results First Posted: October 10, 2014

Record last verified: 2014-10

Locations

US (2)