Overview

This trial is active, not recruiting.

Condition hiv infections
Treatments truvada (tenofovir/emitricitabine), kaletra (lopinavir/ritonavir)
Phase phase 4
Sponsor University of Cincinnati
Collaborator Abbott
Start date October 2005
End date August 2009
Trial size 60 participants
Trial identifier NCT00885664, IDC 30

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
truvada (tenofovir/emitricitabine) Truvada
Tenofovir/emitricitabine fixed dose combination once daily
(Active Comparator)
kaletra (lopinavir/ritonavir) Kaletra
Lopinavir/ritonavir 400/100 mg twice daily

Primary Outcomes

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

Secondary Outcomes

Measure
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

Male or female participants at least 18 years old.

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.

Additional Information

Official title Immune Reconstitution as a Determinant of Adverse Effects to New Antiretroviral Therapy in Persons With Advanced HIV Infection
Principal investigator Carl J Fichtenbaum, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2009.
Information provided to ClinicalTrials.gov by University of Cincinnati.