Status:
COMPLETED
Immune Reconstitution as a Determinant of Adverse Effects to New Antiretroviral Therapy in Persons With Advanced HIV Infection
Lead Sponsor:
University of Cincinnati
Collaborating Sponsors:
Abbott
Gilead Sciences
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 c...
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....
Eligibility Criteria
Inclusion
- Age \> 18 years
- Diagnosis of HIV infection.
- Naive to antiretroviral therapy OR no use of antiretrovirals for ≥ 6 months.
Exclusion
- Blinded drug treatment.
- 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.
- Known resistance to proposed new HIV regimen or components of regimen.
- Requirement for drug therapy with known contraindication with proposed new antiretroviral therapy (see Prohibited and Precautionary Medications below)
- Pregnancy or breast feeding.
- 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.
- 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 Cockcroft-Gault method is defined on page 33.
- 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.
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00885664
Start Date
October 1 2005
End Date
March 1 2010
Last Update
August 10 2022
Active Locations (1)
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1
University of Cincinnati AIDS Clinical Trials Unit
Cincinnati, Ohio, United States, 45267