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Immune Reconstitution as a Determinant of Adverse Effects to New Antiretroviral Therapy in Persons With Advanced HIV Infection

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ClinicalTrials.gov Identifier: NCT00885664
Recruitment Status : Unknown
Verified April 2009 by University of Cincinnati.
Recruitment status was:  Active, not recruiting
First Posted : April 22, 2009
Last Update Posted : May 15, 2009
Sponsor:
Collaborators:
Abbott
Gilead Sciences
Information provided by:
University of Cincinnati

Study Description
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Brief Summary:

The purposes of this study are:

  1. To understand whether the use of HIV therapy in persons with more advanced HIV disease results in greater side effects.
  2. To determine whether these side effects can be related to greater activation of the immune system.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Truvada (tenofovir/emitricitabine) Drug: Kaletra (lopinavir/ritonavir) Phase 4

Detailed Description:
  1. To compare the incidence and severity of self-reported symptoms in persons with CD4 counts <100 cells/mm3 versus those with CD4 counts ≥ 100 cells/mm3 who are initiating antiretroviral therapy.
  2. To determine the relationship between self-reported symptoms and levels of T cells, HIV RNA, activation marker cytokines including TNF-α, IFN-γ, IL-2, IL-4, IL-6, IL-10 and other cytokines as measured before and after the initiation of antiretroviral therapy.
  3. To determine the relationship between antiretroviral drug trough levels (estimated drug concentrations) and the incidence and severity of self-reported symptoms in persons initiating antiretroviral therapy.
  4. To determine the relationship between adverse events and immunological status as evidenced by lymphocyte counts and activation marker cytokine levels.
  5. To determine the relationship between clinical events and immunological status as evidenced by lymphocyte counts and activation marker cytokine levels.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Immune Reconstitution as a Determinant of Adverse Effects to New Antiretroviral Therapy in Persons With Advanced HIV Infection
Study Start Date : October 2005
Estimated Primary Completion Date : August 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Truvada Drug: Truvada (tenofovir/emitricitabine)
Tenofovir/emitricitabine fixed dose combination once daily
Other Name: Truvada
Active Comparator: Kaletra Drug: Kaletra (lopinavir/ritonavir)
Lopinavir/ritonavir 400/100 mg twice daily
Other Name: Kaletra


Outcome Measures
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Primary Outcome Measures :
  1. To compare the incidence and severity of self-reported symptoms in persons with CD4 counts <100 cells/mm3 versus those with CD4 counts ≥ 100 cells/mm3 who are initiating antiretroviral therapy. [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. To determine the relationship between symptoms and levels of T cells, HIV RNA, activation marker cytokines including TNF-α, IFN-γ, IL-2, IL-4, IL-6, IL-10 and other cytokines before and after the initiation of antiretroviral therapy. [ Time Frame: 24 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age > 18 years
  2. Diagnosis of HIV infection.
  3. Naive to antiretroviral therapy OR no use of antiretrovirals for ≥ 6 months.

Exclusion Criteria:

  1. Blinded drug treatment.
  2. Active untreated serious infection within 14 days of enrollment that in the opinion of the investigator would affect the subject's participation and/or safety in the study.
  3. Known resistance to proposed new HIV regimen or components of regimen.
  4. Requirement for drug therapy with known contraindication with proposed new antiretroviral therapy (see Prohibited and Precautionary Medications below)
  5. Pregnancy or breast feeding.
  6. Liver enzyme abnormalities on screening. Patients who have symptomatic Grade 3 elevations of total bilirubin, AST, ALT, or alkaline phosphatase or Grade > 3 elevations of total bilirubin, AST, ALT, or alkaline phosphatase will be excluded. Patients who have asymptomatic grade 3 elevations of total bilirubin, AST, ALT, or alkaline phosphatase may be included in the study at the discretion of the primary physician in consultation with the principal or senior investigator. Patients with grade 3 elevations of liver function tests who are co-infected with hepatitis B or hepatitis C may be included in the study at the discretion of the primary care physician in consultation with the primary or senior investigator provided that they do not have signs or symptoms of clinical hepatitis. Signs of clinical hepatitis include: icterus, abdominal tenderness and hepatosplenomegaly. Symptoms of clinical hepatitis include: fever, abdominal pain, anorexia, nausea, vomiting, fatigue, malaise, and myalgia.
  7. Decreased creatinine clearance at the time of screening. Patients with a creatinine clearance of <50mL/min as calculated by the Cockcroft-Gault method should be excluded from study entry. The Cockroft-Gault method is defined on page 33.
  8. Other Grade ≥3 lab abnormalities. For any other laboratory abnormalities of grade 3 or higher, patients may be included or excluded from the study at the discretion of the primary care physician in consultation with the primary or senior investigator.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00885664


Locations
United States, Ohio
University of Cincinnati AIDS Clinical Trials Unit
Cincinnati, Ohio, United States, 45267
Sponsors and Collaborators
University of Cincinnati
Abbott
Gilead Sciences
Investigators
Principal Investigator: Carl J Fichtenbaum, MD University of Cincinnati
More Information
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Responsible Party: Carl J. Fichtenbaum, MD, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00885664     History of Changes
Other Study ID Numbers: IDC 30
First Posted: April 22, 2009    Key Record Dates
Last Update Posted: May 15, 2009
Last Verified: April 2009

Keywords provided by University of Cincinnati:
HIV
immune reconstitution
treatment naive

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Ritonavir
Lopinavir
 Tenofovir
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors