Transplantation and the Use of Raltegravir in HIV-Infected Patients

NCT01793467 | Completed

• 1 other identifier: Pro00036598
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

Raltegravir (RAL) is a preferred option for initial antiretroviral therapy in the most recent HIV Treatment Guidelines and is emerging as a popular choice for use in the specialized population of HIV-infected patients being considered for solid organ transplantation. Data from HIV-infected persons with normal organ function have revealed few raltegravir-associated metabolic complications compared to older antiretrovirals, and in general, drug-drug interactions with raltegravir are infrequent. The absence of such concerns appears to make raltegravir a potentially appealing option for antiretroviral therapy in HIV-infected patients being considered for solid organ transplantation. At present, however, little is known of the safety and long term tolerability of RAL-containing regimens in persons undergoing solid organ transplantation. As more HIV-infected patients undergo organ transplantation, there is a growing need for good data on such things as the effect of dialysis on RAL concentrations, the potential interactions with commonly used immunosuppressive drugs, and the pharmacokinetic (PK) /pharmacodynamic (PD) characteristics in those with end stage organ failure, as well as those with functioning grafts. The proposed study will also examine transplant function and survival in HIV-infected patients receiving RAL-containing ART and will compare it to HIV negative historic controls.

Conditions

HIV Positive; Organ Transplant Recipient; Active Wait Listing for Organ Transplant

Outcome Measures

Primary Outcomes (1)

• To examine raltegravir (RAL) in the management of HIV-infected persons listed for solid organ transplantation, with a focus on mortality and graft survival

  3+ years

Secondary Outcomes (2)

• Assess Raltegravir viability as a long term HIV treatment drug for patients undergoing transplant

  3+ years

• determine the viability of grafted organs in patients with HIV infections

  3+ years

Eligibility Criteria

• Age: 13 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HIV positive patients, awaiting or listed for organ transplantation, currently taking Raltegravir

You may qualify if:

• non-pregnant adult patient with CD4 count \>200/μL
• no concurrent active AIDS-defining infections or malignancy
• at least 24 months of well controlled HIV viremia, defined as \<50 copies for the majority of the time.
• otherwise suitable transplant candidates, actively listed
• currently taking Raltegravir for control of HIV infection

Sponsors & Collaborators

• Duke University: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 277138270, United States

Location

MeSH Terms

Conditions

HIV Seropositivity

Condition Hierarchy (Ancestors)

HIV Infections; 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

Study Officials

• Cameron R Wolfe, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2013
• First Posted: February 15, 2013
• Study Start: October 1, 2012
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: August 16, 2017

Record last verified: 2017-07

Locations

US (1)