Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by University of Cincinnati.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Abbott
Gilead Sciences
Information provided by:
University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00885664
First received: April 20, 2009
Last updated: May 14, 2009
Last verified: April 2009

April 20, 2009
May 14, 2009
October 2005
August 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00885664 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Immune Reconstitution as a Determinant of Adverse Effects to New Antiretroviral Therapy in Persons With Advanced HIV Infection
Immune Reconstitution as a Determinant of Adverse Effects to New Antiretroviral Therapy in Persons With Advanced HIV Infection

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.
  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.
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: Truvada (tenofovir/emitricitabine)
    Tenofovir/emitricitabine fixed dose combination once daily
    Other Name: Truvada
  • Drug: Kaletra (lopinavir/ritonavir)
    Lopinavir/ritonavir 400/100 mg twice daily
    Other Name: Kaletra
  • Active Comparator: Truvada
    Intervention: Drug: Truvada (tenofovir/emitricitabine)
  • Active Comparator: Kaletra
    Intervention: Drug: Kaletra (lopinavir/ritonavir)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
December 2009
August 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00885664
IDC 30
No
Carl J. Fichtenbaum, MD, University of Cincinnati
University of Cincinnati
  • Abbott
  • Gilead Sciences
Principal Investigator: Carl J Fichtenbaum, MD University of Cincinnati
University of Cincinnati
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP