Pitt Treatment Evaluation Unit
PTEU
Currently Enrolling PTEU Studies
- (A5146) – Therapeutic drug monitoring (TDM) in those failing a PI-based regimen
Objective: To evaluate the impact of TDM on virologic response in salvage therapy
Include: viral load >1000; failing a regimen with a PI; viral load >400 within 6 months of study entry; willing to start a PI-containing salvage regimen
Exclude: active pancreatitis or history of chronic pancreatitis
- (A5197) – Merck Ad5 HIV-1 gag vaccine study
Objective: To determine if Merck vaccine has effect on viral suppression in patients with undetectable viral loads willing to stop ARV therapy
Include: VL <50 at study entry, <500 12 months prior to entry; two consecutive VL >500 12 months prior to study; CD4 >500 at entry; two consecutive CD4 <300 prior to ART
Exclude: previous HIV vaccine; HCV; history of OI; over age 50 at entry
- (A5200) – anti-HIV activity and safety of mifepristone
Include: CD4 > 350; VL > 2,000; no HIV meds for 16 weeks prior to study entry
Exclude: active HBV or HCV; renal failure; diabetes; no ED meds on study
- (A5211) – using an oral CCR-5 receptor inhibitor to block HIV from entering healthy t-cells
Objective: To determine if treatment-experienced patients will demonstrate viral suppression with an oral CCR-5 inhibitor and a ritonavir-containing regimen
Include: on failing regimen that contains ritonavir; VL >5,000
Exclude: efavirenz or nevirapine within 56 days of study entry
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PTEU Studies Enrolling Soon
- (A5202) – for those naïve to HIV treatment
- (A5206) – impact on dislipidemia with Tenofovir
- (A5209) - Zetia + statins in reducing LDL cholesterol
- (A5223) - sex-differences/PK study of Kaletra
- (Merck 05) - safety and efficacy of Integrase
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