Overview

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

Status:
Unknown status
Trial end date:
2009-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Cincinnati
Collaborators:
Abbott
Gilead Sciences
Treatments:
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Lopinavir
Ritonavir
Tenofovir
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.