Comparison of TPV/r to DRV/r in Triple Class Experienced... | NCT00517192

Measure	Description	Time Frame
Time to Virologic Failure Through 48 Weeks of Treatment, Using Viral Load (VL) < 50 Copies/Millilitre (mL) as the Response Criterion.		48 weeks of treatment

Measure	Description	Time Frame
Treatment Response at Week 48, Using VL < 50 Copies/mL as the Response Criterion and the FDA Definition for Handling Drug Discontinuations ((NCF) Non-Completers=Failure).		48 weeks of treatment
Intent-To-Treat Analysis of Virologic Response at Week 48, Using VL < 50 Copies/mL as the Response Criterion Where Patients Are Followed Until Week 48 for VL Regardless of Whether or Not They Remain on Study Drug.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Signed informed consent prior to trial participation.
HIV-1 infected male or female >18 years of age.
Three-class (NRTI, NNRTI, and PI) treatment-experienced patients (a minimum of 3-months duration for each class or documented class hypersensitivity/intolerance) with resistance (minimal or reduced response) to more than one PI on the screening virtual phenotype resistance testing. In the case of NNRTIs, NNRTI resistance in the absence of exposure is equivalent to being NNRTI treatment experienced.
Patient's optimized background regimen must contain one of the following ARV options:
- A minimum of two genotypically active nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) reported as "maximal response" or "sensitive" on the screening virtual phenotype report.
- A minimum of one genotypically active NRTI reported as "maximal response" or "sensitive" on the screening virtual phenotype report plus Enfuvirtide if not used previously.
- A minimum of one genotypically active NRTI reported as "maximal response" or "sensitive" on the screening virtual phenotype report plus an integrase inhibitor if not used previously and if available through an expanded access program and allowed by local regulatory authorities.
- A minimum of one genotypically active NRTI reported as "maximal response" or "sensitive" on the screening virtual phenotype report plus the CCR5 chemokine receptor antagonist Maraviroc if available through an expanded access program, not used previously and allowed by local regulatory authorities.
- Zero or one genotypically active NRTI reported as "maximal response" or "sensitive" on the screening virtual phenotype report plus two of the following drugs, Enfuvirtide, an integrase inhibitor and Maraviroc if available, not used previously and allowed by local regulatory authorities.
- Two genotypically partially active NRTIs (provided that they are not part of the current failing regimen) reported as "reduced response" on the screening virtual phenotype report plus one of the following drugs, Enfuvirtide, an integrase inhibitor or Maraviroc if available, not used previously and allowed by local regulatory authorities.
Patient has been on their current (failing) PI-containing regimen for at least 8 weeks prior to randomization.
Patient has on-going viral replication (defined as an HIV-1 viral load of ≥ 500 copies/mL) and a successful virtual phenotype obtained at screening.
Any baseline CD4 cell count will be allowed.
Karnofsky performance score of ≥ 70.
Acceptable screening laboratory values that indicate adequate baseline organ function. Laboratory values are considered acceptable if the following apply:
- ALT ≤2.5 x ULN and AST ≤2.5 x ULN (≤DAIDS Grade 1, Appendix 10.1).
- Any DAIDS grade cholesterol, triglycerides, GGT, CPK or LDH is acceptable.
- All other laboratory test values must be ≤DAIDS Grade 2.
Willingness to initiate CD4+ cell count-guided chemoprophylaxis to prevent opportunistic infections.
Willingness to abstain from ingesting substances which may alter plasma study drug levels by interaction with the cytochrome P450 system during the study.

Inclusion Criteria:

Previous use of Tipranavir (TPV) or Darunavir (DRV).
Full genotypic resistance (reported as minimal response) to Tipranavir (TPV) or Darunavir (DRV) on screening virtual phenotype:
Female patient of child-bearing potential who:

has a positive serum pregnancy test at screening, is breast feeding, is planning to become pregnant, is not willing to use double-barrier methods (simultaneous use of two different methods such as diaphragm with spermicidal substance and condom) of contraception or requires ethinyl estradiol administration. Barrier methods of contraception include diaphragm with spermicidal substance, condom for females, cervical caps and condoms.
History of Progressive Multifocal Leukoencephalopathy (PML), Visceral Kaposi's Sarcoma (KS), and/or any malignancy.
Any AIDS defining illness that is unresolved, symptomatic or not stable on treatment for at least 12 weeks at screening visit.
Use of immunomodulatory drugs (such as interferon, cyclosporin, hydroxyurea and interleukin 2) within 30 days prior to randomization.
Current use of systemic cytotoxic chemotherapy.
All contraindications listed in the product monographs of Aptivus, Prezista and Norvir.

Name	Affiliation	Role
Boehringer Ingelheim	Boehringer Ingelheim	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
1182.71.1109 Boehringer Ingelheim Investigational Site		Beverly Hills	California		United States

PubMed Identifier	Type	Citation	Retractions
22007990	Derived	Elgadi MM, Piliero PJ. Boosted tipranavir versus darunavir in treatment-experienced patients: observational data from the randomized POTENT trial. Drugs R D. 2011 Dec 1;11(4):295-302. doi: 10.2165/11596340-000000000-00000.

ID	Title	Description
FG000	Tipranavir 500 mg/Ritonavir 200 mg	Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
FG001	Darunavir 600 mg/Ritonavir 100 mg

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Time to Virologic Failure Through 48 Weeks of Treatment, Using Viral Load (VL) < 50 Copies/Millilitre (mL) as the Response Criterion.

Posted

48 weeks of treatment

ID	Title	Description
OG000	Tipranavir 500 mg/Ritonavir 200 mg	Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
OG001	Darunavir 600 mg/Ritonavir 100 mg	Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral

Units	Counts
Participants	OG0000 OG0010

Secondary

Treatment Response at Week 48, Using VL < 50 Copies/mL as the Response Criterion and the FDA Definition for Handling Drug Discontinuations ((NCF) Non-Completers=Failure).

Posted

48 weeks of treatment

ID	Title	Description
OG000	Tipranavir 500 mg/Ritonavir 200 mg	Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
OG001	Darunavir 600 mg/Ritonavir 100 mg	Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral

Units	Counts
Participants	OG000

Secondary

Intent-To-Treat Analysis of Virologic Response at Week 48, Using VL < 50 Copies/mL as the Response Criterion Where Patients Are Followed Until Week 48 for VL Regardless of Whether or Not They Remain on Study Drug.

Posted

48 weeks of treatment

ID	Title	Description
OG000	Tipranavir 500 mg/Ritonavir 200 mg	Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
OG001	Darunavir 600 mg/Ritonavir 100 mg	Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral

Units	Counts
Participants	OG000

Secondary

Time to Virologic Failure Through 48 Weeks of Treatment, Using VL < 400 Copies/mL as the Response Criterion.

Posted

48 weeks of treatment

ID	Title	Description
OG000	Tipranavir 500 mg/Ritonavir 200 mg	Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
OG001	Darunavir 600 mg/Ritonavir 100 mg	Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral

Units	Counts
Participants	OG000

Secondary

Response up to 48 Weeks Using VL < 50 Copies/mL Using Censored

Posted

up to 48 weeks

ID	Title	Description
OG000	Tipranavir 500 mg/Ritonavir 200 mg	Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
OG001	Darunavir 600 mg/Ritonavir 100 mg	Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral

Units	Counts
Participants	OG000

Secondary

Response up to 48 Weeks Using VL < 50 Copies/mL Using NCF

Posted

up to 48 weeks

ID	Title	Description
OG000	Tipranavir 500 mg/Ritonavir 200 mg	Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
OG001	Darunavir 600 mg/Ritonavir 100 mg	Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral

Units	Counts
Participants	OG000

Secondary

Response up to 48 Weeks Using VL < 50 Copies/mL Using Intent-to-treat

Posted

up to 48 weeks

ID	Title	Description
OG000	Tipranavir 500 mg/Ritonavir 200 mg	Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
OG001	Darunavir 600 mg/Ritonavir 100 mg	Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral

Units	Counts
Participants	OG000

Secondary

Response up to 48 Weeks Using VL < 400 Copies/mL Using Censored

Posted

up to 48 weeks

ID	Title	Description
OG000	Tipranavir 500 mg/Ritonavir 200 mg	Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
OG001	Darunavir 600 mg/Ritonavir 100 mg	Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral

Units	Counts
Participants	OG000

Secondary

Response up to 48 Weeks Using VL < 400 Copies/mL Using NCF

Posted

up to 48 weeks

ID	Title	Description
OG000	Tipranavir 500 mg/Ritonavir 200 mg	Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
OG001	Darunavir 600 mg/Ritonavir 100 mg	Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral

Units	Counts
Participants	OG000

Secondary

Response up to 48 Weeks Using VL < 400 Copies/mL Using Intent-to-treat

Posted

up to 48 weeks

ID	Title	Description
OG000	Tipranavir 500 mg/Ritonavir 200 mg	Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
OG001	Darunavir 600 mg/Ritonavir 100 mg	Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral

Units	Counts
Participants	OG000

Secondary

Response up to 48 Weeks Using at Least a 1 log10 Reduction in Viral Load From Baseline Using Censored

Posted

up to 48 weeks

ID	Title	Description
OG000	Tipranavir 500 mg/Ritonavir 200 mg	Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
OG001	Darunavir 600 mg/Ritonavir 100 mg	Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral

Units	Counts
Participants	OG000

Secondary

Response up to 48 Weeks Using at Least a 1 log10 Reduction in Viral Load From Baseline Using NCF

Posted

up to 48 weeks

ID	Title	Description
OG000	Tipranavir 500 mg/Ritonavir 200 mg	Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
OG001	Darunavir 600 mg/Ritonavir 100 mg	Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral

Units	Counts
Participants	OG000

Secondary

Response up to 48 Weeks Using at Least a 1 log10 Reduction in Viral Load From Baseline Using Intent-to-treat

Posted

up to 48 weeks

ID	Title	Description
OG000	Tipranavir 500 mg/Ritonavir 200 mg	Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
OG001	Darunavir 600 mg/Ritonavir 100 mg	Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral

Units	Counts
Participants	OG000

Secondary

Daily Average in CD4+ Cell Count Change From Baseline at up to Week 8

Posted

up to week 8

ID	Title	Description
OG000	Tipranavir 500 mg/Ritonavir 200 mg	Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
OG001	Darunavir 600 mg/Ritonavir 100 mg	Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral

Units	Counts
Participants	OG000

Secondary

Daily Average in CD4+ Cell Count Change From Baseline up to Week 24

Posted

up to week 24

ID	Title	Description
OG000	Tipranavir 500 mg/Ritonavir 200 mg	Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
OG001	Darunavir 600 mg/Ritonavir 100 mg	Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral

Units	Counts
Participants	OG000

Secondary

Daily Average in CD4+ Cell Count Change From Baseline up to Week 48

Posted

up to week 48

ID	Title	Description
OG000	Tipranavir 500 mg/Ritonavir 200 mg	Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
OG001	Darunavir 600 mg/Ritonavir 100 mg	Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral

Units	Counts
Participants	OG000

Secondary

Daily Average in Viral Load Change From Baseline up to Week 8

Posted

up to week 8

ID	Title	Description
OG000	Tipranavir 500 mg/Ritonavir 200 mg	Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
OG001	Darunavir 600 mg/Ritonavir 100 mg	Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral

Units	Counts
Participants	OG000

Secondary

Daily Average in Viral Load Change From Baseline up to Week 24

Posted

up to week 24

ID	Title	Description
OG000	Tipranavir 500 mg/Ritonavir 200 mg	Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
OG001	Darunavir 600 mg/Ritonavir 100 mg	Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral

Units	Counts
Participants	OG000

Secondary

Daily Average in Viral Load Change From Baseline up to Week 48

Posted

up to week 48

ID	Title	Description
OG000	Tipranavir 500 mg/Ritonavir 200 mg	Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
OG001	Darunavir 600 mg/Ritonavir 100 mg	Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral

Units	Counts
Participants	OG000

Secondary

Change From Baseline in CD4+ Cell Count up to Week 48

Posted

up to week 48

ID	Title	Description
OG000	Tipranavir 500 mg/Ritonavir 200 mg	Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
OG001	Darunavir 600 mg/Ritonavir 100 mg	Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral

Units	Counts
Participants	OG000

Secondary

Change From Baseline in log10 Viral Load up to Week 48

Posted

up to week 48

ID	Title	Description
OG000	Tipranavir 500 mg/Ritonavir 200 mg	Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
OG001	Darunavir 600 mg/Ritonavir 100 mg	Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral

Units	Counts
Participants	OG000

Secondary

Occurrence of New AIDS Progression Events or Death

Posted

through 48 weeks of treatment

ID	Title	Description
OG000	Tipranavir 500 mg/Ritonavir 200 mg	Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
OG001	Darunavir 600 mg/Ritonavir 100 mg	Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral

Units	Counts
Participants	OG000

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Angina pectoris	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected20 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected20 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected20 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0003 affected19 at risk EG0013 affected20 at risk
Nausea	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected19 at risk EG0011 affected20 at risk
Odynophagia	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected20 at risk
Vomiting	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected19 at risk EG0011 affected20 at risk
Asthenia	General disorders	MedDRA 12.0	Systematic Assessment	EG0002 affected19 at risk EG0010 affected20 at risk
Fatigue	General disorders	MedDRA 12.0	Systematic Assessment	EG0002 affected19 at risk EG0010 affected20 at risk
Pyrexia	General disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected19 at risk EG0012 affected20 at risk
Cytolytic hepatitis	Hepatobiliary disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected20 at risk
Bronchitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0002 affected19 at risk EG0010 affected20 at risk
Subcutaneous abscess	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected20 at risk
Tracheitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected20 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA 12.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected20 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected20 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected19 at risk EG0011 affected20 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected20 at risk
Dizziness	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected20 at risk
Headache	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected19 at risk EG0013 affected20 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0002 affected19 at risk EG0011 affected20 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected20 at risk
Facial wasting	Skin and subcutaneous tissue disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected19 at risk EG0010 affected20 at risk

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral
D012749	Sexually Transmitted Diseases
D016180	Lentivirus Infections
D012192	Retroviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D007153	Immunologic Deficiency Syndromes
D007154	Immune System Diseases

ID	Term
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals
D002219	Carbamates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D013450	Sulfones
D013457	Sulfur Compounds
D005663	Furans
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D013844	Thiazoles
D001393	Azoles

ID	Title	Description
BG000	Tipranavir 500 mg/Ritonavir 200 mg	Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
BG001	Darunavir 600 mg/Ritonavir 100 mg	Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Tipranavir 500 mg/Ritonavir 200 mg	Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral			0	19	12	19
EG001	Darunavir 600 mg/Ritonavir 100 mg	Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral			2	20	7	20

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Neutropenia	Blood and lymphatic system disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected20 at risk
Gangrene	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected20 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected20 at risk
Peroneal nerve palsy	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected20 at risk
Radiculopathy	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected20 at risk
Iliac artery thrombosis	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected20 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected19 at risk EG0011 affected20 at risk