Date Informed Consent Obtained (Date informed consent obtained)
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Does The Participant Have A Ast (sgot) And Alt (sgpt) <=2.5 Times The Uln (Does the participant have a AST (SGOT) and ALT (SGPT) <=2.5 times the ULN)
CL Item
Does The Participant Have A Fasting Triglyceride Level Of <= 400 Mg/dl (4.5 Mmol/l), And A Total Cholesterol Level Of <= 300 Mg/dl (7.8 Mmol/l) (Does the participant have a fasting triglyceride level of <= 400 mg/dL (4.5 mmol/L), and a total cholesterol level of <= 300 mg/dL (7.8 mmol/L))
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Does The Participant Have A Total Bilirubin <= 1.5 Times Upper Limit Of Normal (uln) (Does the participant have a Total bilirubin <= 1.5 times upper limit of normal (ULN))
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Does The Participant Have Biopsy-proven Ks Involving The Skin, Lymph Nodes, Oral Cavity, Gi Tract And/or Lungs (gi And Pulmonary Involvement Must Be Asymptomatic Or Minimally Symptomatic And Not Require Systemic Cytotoxic Therapy) (Does the participant have biopsy-proven KS involving the skin, lymph nodes, oral cavity, GI tract and/or lungs (GI and pulmonary involvement must be asymptomatic or minimally symptomatic and not require systemic cytotoxic therapy))
CL Item
Does The Participant Have Serologic Documentation Of Hiv Infection At Any Time Prior To Study Entry, As Evidenced By Positive Elisa, Positive Western Blot, Or Other Federally Approved Licensed Hiv Test, Or A Detectable Blood Level Of Hiv Rna (Does the participant have serologic documentation of HIV infection at any time prior to study entry, as evidenced by positive ELISA, positive Western Blot, or other federally approved licensed HIV test, or a detectable blood level of HIV RNA)
CL Item
Does The Participant Have The Ability And Willingness To Give Informed Consent (Does the participant have the ability and willingness to give informed consent)
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Does The Participant Have The Following Laboratory Parameters Within 21 Days Prior To Study Entry: Hemoglobin >= 8.0 Gm/dl; Absolute Neutrophil Count >= 1000 Cells/mm3; Platelet Count >= 75,000/mm3 (Does the participant have the following laboratory parameters within 21 days prior to study entry: Hemoglobin >= 8.0 gm/dL; Absolute neutrophil count >= 1000 cells/mm3; Platelet count >= 75,000/mm3)
CL Item
Does The Participant, Male Or Female, Of Reproductive Age, Agree To Employ An Effective Barrier Method Of Birth Control Throughout The Study And For Up To 3 Months Following Discontinuation Of Study Drug (Does the participant, male or female, of reproductive age, agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug)
CL Item
Gfr > 40 Ml/min (calculated By The Cockcroft-gault Equation), Calculated As Follows For Males = 140 - Age [years]) X (body Weight [kg]) / (72) X (serum Creatinine [mg/dl]; For Females = 0.85 X Male Value (GFR > 40 mL/min (calculated by the Cockcroft-Gault equation), calculated as follows For males = 140 - age [years]) x (body weight [kg]) / (72) x (serum creatinine [mg/dL]; For females = 0.85 x male value)
CL Item
Has The Participant Been On Stable Anti-retroviral Therapy For At Least 12 Weeks With A Pi-based Or Nnrti-based Regimen Of At Least Three Drugs, With No Intention To Change The Regimen Within 8 Weeks Of Starting Study Drug (Has the participant been on stable anti-retroviral therapy for at least 12 weeks with a PI-based or NNRTI-based regimen of at least three drugs, with no intention to change the regimen within 8 weeks of starting study drug)
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Has The Participant Had No Prior Treatment With Rapamycin (Has the participant had no prior treatment with rapamycin)
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If The Participant Is Female, Did She Have A Negative Pregnancy Test Within 72 Hours Before Initiation Of Study Drug Dosing (If the participant is female, did she have a negative pregnancy test within 72 hours before initiation of study drug dosing)
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Is The Participant's Cd4 Count >50 Cells/ul And Serum Hiv Rna Level <400 Copies/ml (Is the participant's CD4 count >50 cells/uL and serum HIV RNA level <400 copies/mL)
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Is The Participant's Life Expectancy 3 Months Or More (Is the participant's life expectancy 3 months or more)
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Is The Participant, In The Opinion Of The Investigator, Capable Of Complying With This Protocol (Is the participant, in the opinion of the Investigator, capable of complying with this protocol)
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Karnofsky Performance Status (must Be > 60%) (Karnofsky Performance Status (must be > 60%))
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Participant's Age (in Years) (Participant's age (in years))
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Regarding The Participant's Spot Urine Protein: Is The Creatinine Ratio <= 0.5 And/or Proteinuria <= 500 Mg/day (Regarding the participant's spot urine protein: Is the creatinine ratio <= 0.5 and/or proteinuria <= 500 mg/day)
Does The Participant Have A Grade Iii/iv Cardiac Disease As Defined By The New York Heart Association Criteria (e.g., Congestive Heart Failure, Myocardial Infarction Within 6 Months Of Study) (Does the participant have a Grade III/IV cardiac disease as defined by the New York Heart Association criteria (e.g., congestive heart failure, myocardial infarction within 6 months of study))
CL Item
Does The Participant Have A History Of Prior Or Concurrent Malignancy Except For Treated Basal Cell Skin Cancer Or A Cervical Carcinoma In Situ (Does the participant have a history of prior or concurrent malignancy except for treated basal cell skin cancer or a cervical carcinoma in situ)
CL Item
Does The Participant Have An Acute Or Known Chronic Liver Disease (e.g., Chronic Active Hepatitis, Cirrhosis) (participants With Known Hepatitis C Infection But With Documentation Of No Or Minimal Fibrosis On Liver Biopsy May Be Enrolled) (Does the participant have an acute or known chronic liver disease (e.g., chronic active hepatitis, cirrhosis) (Participants with known Hepatitis C infection but with documentation of no or minimal fibrosis on liver biopsy may be enrolled))
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Does The Participant Have Another Severe And/or Life-threatening Medical Disease (Does the participant have another severe and/or life-threatening medical disease)
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Does The Participant Have Any Known Hypersensitivity To Rapamycin Or Its Derivatives Or Macrolide Antibiotics (Does the participant have any known hypersensitivity to rapamycin or its derivatives or macrolide antibiotics)
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Does The Participant Have Concurrent Active Opportunistic Infection (oi) (Does the participant have concurrent active opportunistic infection (OI))
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Has The Participant Had Acute Treatment For An Infection Or Other Serious Medical Illness Within 14 Days Prior To Study Entry; Evidence Of Infiltrate, Cavitation Or Consolidation On Chest X-ray Obtained Before Or At The Time Of The Screening Evaluation (Has the participant had acute treatment for an infection or other serious medical illness within 14 days prior to study entry; evidence of infiltrate, cavitation or consolidation on chest x-ray obtained before or at the time of the screening evaluation)
CL Item
Has The Participant Had Antineoplastic Treatment For Ks (including Chemotherapy, Radiation Therapy, Biological Therapy, Or Investigational Therapy) Within 4 Weeks (6 Weeks For Nitrosourea Or Mitomycin-c) Of Study Entry (Has the participant had antineoplastic treatment for KS (including chemotherapy, radiation therapy, biological therapy, or investigational therapy) within 4 weeks (6 weeks for nitrosourea or mitomycin-C) of study entry)
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Has The Participant Had Major Surgery Within 2 Weeks Prior To Study Entry (Has the participant had major surgery within 2 weeks prior to study entry)
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Has The Participant Had Previous Local Therapy Of Any Ks Indicator Lesion Within 60 Days, Unless The Lesion Has Progressed Since Treatment (Has the participant had previous local therapy of any KS indicator lesion within 60 days, unless the lesion has progressed since treatment)
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Has The Participant Had Systemic Corticosteroid Treatment, Other Than Replacement Doses (Has the participant had systemic corticosteroid treatment, other than replacement doses)
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Has The Participant Used Any Investigational Drug Or Treatment Up To 4 Weeks Before Randomization (Has the participant used any investigational drug or treatment up to 4 weeks before randomization)
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If The Participant Is Female, Is She Pregnant Or Breast-feeding (If the participant is female, is she pregnant or breast-feeding)
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Is The Participant Receiving Treatment With Agents Or Medications, Other Than Antiretroviral Drugs Used To Treat Hiv Infection, Which Would Interfere With The Metabolism Or Excretion Of Rapamycin (Is the participant receiving treatment with agents or medications, other than antiretroviral drugs used to treat HIV infection, which would interfere with the metabolism or excretion of rapamycin)