SPRING: Safety, Efficacy, Pharmacokinetics of tipRanavir/... | NCT00440271

NCT00440271

ID	Type	Description	Link
EudraCT No.: 2005-005264-86

Status Module

Sponsor/Collaborators Module

Oversight Module

No data available

No data is available for this block.

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Standard of Care (SoC)	Other	Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.	Drug: tipranavir Drug: ritonavir Drug: Optimized Background Regimen (OBR)
Therapeutic Drug Monitoring (TDM)	Other	Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.	Drug: tipranavir Drug: ritonavir Drug: Optimized Background Regimen (OBR)

Name	Type	Description	Arm Group Labels	Other Names
tipranavir	Drug		Standard of Care (SoC) Therapeutic Drug Monitoring (TDM)
ritonavir

Outcomes Module

Measure	Description	Time Frame
Treatment Response at Week 48	percentage of participants whose viral load <50 copies/mL at Week 48	after 48 weeks of treatment

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants Whose Viral Load <50 Copies/mL at Each Visit Including Visits at Weeks 24 and 48		after 2 weeks of treatment (Weeks 2, 4, 8, 12, 24, 36, and 48)
Percentage of Participants Whose Viral Load <400 Copies/mL at Each Visit Including Visits at Weeks 24 and 48

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Main inclusion criteria for the study are:

HIV-1 infected adults, men and women at least 18 years of age.
3-class (nucleoside reverse transcriptase inhibitor (NRTI), non-nucleoside reverse transcriptase inhibitor (NNRTI), and protease inhibitor (PI)) treatment-experienced (min of 3-months duration for each class) with resistance to more than one PI (on screening resistance testing). NNRTI-naïve patients who have genotypically documented NNRTI-resistance mutations on past or screening resistance testing would be eligible.
CD4+ T lymphocyte count >=50 cells/mm3.
HIV-1 viral load >=1,000 copies/mL at screening.
The antiretroviral (ARV) study treatment regimen must consist of TPV/r in combo with an optimized background regimen (OBR) of 2-4 agents: N(t)RTIs (NRTI or NtRTI), enfuvirtide (ENF), and/or, where available, a trial approved expanded access program (EAP) investigational agent.
Acceptable screening laboratory values that indicate adequate baseline organ function.
Acceptable medical history with a chest X-ray without evidence of active disease and an electrocardiogram (ECG) without clinically important abnormalities within one year of the study.
A reliable method of barrier contraception will be used by all female patients who are of childbearing potential.

Exclusion Criteria:

Main exclusion criteria for the study are:

Known hypersensitivity to the tipranavir (TPV) or ritonavir (RTV).
ARV medication naïve.
Genotypic resistance to TPV (defined as a TPV mutation score >7).
Patients on recent drug holiday, defined as off antiretroviral (ARV) medications for at least 7 consecutive days within the month prior to screening.
Prior tipranavir use.
Inability to adhere to the requirements of the protocol.
Patients with prior history of hemorrhagic stroke or intracranial aneurysm.
Patients with a history of ischemic stroke, neurosurgery or skull trauma within 4 weeks prior to screening.
History of Progressive Multifocal Leukoencephalopathy, Visceral Kaposi's Sarcoma, and/or any malignancy.
Any acquired immunodeficiency syndrome (AIDS) defining illness that is unresolved, symptomatic or not stable on treatment for at least 12 weeks at screening visit.

Contacts/Locations Module

Name	Affiliation	Role
Boehringer Ingelheim	Boehringer Ingelheim	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
1182.98.033 Boehringer Ingelheim Investigational Site		Washington D.C.	District of Columbia		United States

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Standard of Care (SoC)	Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
FG001	Therapeutic Drug Monitoring (TDM)

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Standard of Care (SoC)	Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
BG001	Therapeutic Drug Monitoring (TDM)	Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
Female	BG0003 BG0016 BG002

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

Treatment Response at Week 48

percentage of participants whose viral load <50 copies/mL at Week 48

The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.

Posted

after 48 weeks of treatment

ID	Title	Description
OG000	Standard of Care (SoC)	Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
OG001	Therapeutic Drug Monitoring (TDM)	Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.

Units	Counts
Participants	OG0000 OG0010

Secondary

Percentage of Participants Whose Viral Load <50 Copies/mL at Each Visit Including Visits at Weeks 24 and 48

The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.

Posted

after 2 weeks of treatment (Weeks 2, 4, 8, 12, 24, 36, and 48)

ID	Title	Description
OG000	Standard of Care (SoC)	Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
OG001	Therapeutic Drug Monitoring (TDM)	Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.

Units	Counts
Participants

Secondary

Percentage of Participants Whose Viral Load <400 Copies/mL at Each Visit Including Visits at Weeks 24 and 48

The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.

Posted

after 2 weeks of treatment (Weeks 2, 4, 8, 12, 24, 36, and 48)

ID	Title	Description
OG000	Standard of Care (SoC)	Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
OG001	Therapeutic Drug Monitoring (TDM)	Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.

Units	Counts
Participants

Secondary

Percentage of Participants Whose ≥1 log10 Drop in Viral Load From Baseline at All Visits, Including Visits at Weeks 24 and 48

The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.

Posted

after 2 weeks of treatment (Weeks 2, 4, 8, 12, 24, 36, and 48)

ID	Title	Description
OG000	Standard of Care (SoC)	Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
OG001	Therapeutic Drug Monitoring (TDM)	Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.

Units	Counts
Participants

Secondary

Change in Viral Load From Baseline at Each Visit

The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.

Posted

after 2 weeks of treatment (Weeks 2, 4, 8, 12, 24, 36, and 48)

ID	Title	Description
OG000	Standard of Care (SoC)	Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
OG001	Therapeutic Drug Monitoring (TDM)	Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.

Units	Counts
Participants

Secondary

Time to Treatment Failure

For patients who never achieve a confirmed virologic response, time to treatment failure is defined as 0. For patients who achieve a confirmed virologic response, time to treatment failure is the earliest time of either: death, permanent discontinuation of the study drug or loss to follow-up, introduction of a new anti-retroviral drug to the regimen if it is not solely related to either toxicity or intolerance clearly attributable to a background drug, but not the study drug, or first occurrence of a VL >50 copies/mL at two consecutive measurements after having achieved a VL <50 copies/mL.

The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.

Posted

after Day 1 of treatment

ID	Title	Description
OG000	Standard of Care (SoC)	Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
OG001	Therapeutic Drug Monitoring (TDM)	Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.

Secondary

Time to New AIDS or AIDS Related Progression Event or Death

The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.

Posted

after Day 1 of treatment

ID	Title	Description
OG000	Standard of Care (SoC)	Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
OG001	Therapeutic Drug Monitoring (TDM)	Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.

Units	Counts
Participants	OG000

Secondary

Change in CD4+ and CD8+ Cell Counts From Baseline at Each Visit Including Visits at Week 24 and Week 48

The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.

Posted

after 2 weeks of treatment till Week 48 (Weeks 2, 4, 8, 12, 24, 36, and 48)

ID	Title	Description
OG000	Standard of Care (SoC)	Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
OG001	Therapeutic Drug Monitoring (TDM)	Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.

Units	Counts
Participants

Secondary

Change in Ratio of CD38+/CD8+ From Baseline to Week 48

The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.

Posted

after 2 weeks of treatment till Week 48 (Weeks 2, 4, 8, 12, 24, 36, and 48)

ID	Title	Description
OG000	Standard of Care (SoC)	Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
OG001	Therapeutic Drug Monitoring (TDM)	Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.

Units	Counts
Participants

Secondary

Tipranavir (TPV) and Ritonavir (RTV) Trough Concentrations at Week 2, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48

The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.

Posted

after 2 weeks of treatment till Week 48 (Weeks 2, 4, 8, 12, 24, 36, and 48)

ID	Title	Description
OG000	Standard of Care (SoC)	Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
OG001	Therapeutic Drug Monitoring (TDM)	Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.

Units	Counts
Participants

Secondary

Patients Adherence With Study Medication Based on Pill Count

The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.

Posted

after 4 weeks of treatment

ID	Title	Description
OG000	Standard of Care (SoC)	Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
OG001	Therapeutic Drug Monitoring (TDM)	Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.

Units	Counts
Participants	OG000

Secondary

Occurrence of TPV Inhibitory Quotient (IQ) >60 at Each Visit Where TPV Concentration is Measured

The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.

Posted

after 2 weeks of treatment (Weeks 2, 4, 8, 12, 24, 36, and 48)

ID	Title	Description
OG000	Standard of Care (SoC)	Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
OG001	Therapeutic Drug Monitoring (TDM)	Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.

Units	Counts
Participants

Secondary

Occurrence of TPV Trough Concentration >120 μM

The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints.

Posted

after 2 weeks of treatment (Weeks 2, 4, 8, 12, 24, 36, and 48)

ID	Title	Description
OG000	Standard of Care (SoC)	Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
OG001	Therapeutic Drug Monitoring (TDM)	Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.

Units	Counts
Participants

Secondary

Post-dose TPV and RTV Concentrations at Week 4

Posted

Week 4

ID	Title	Description
OG000	Standard of Care (SoC)	Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
OG001	Therapeutic Drug Monitoring (TDM)	Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Standard of Care (SoC)	Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.			0	15	12	15
EG001	Therapeutic Drug Monitoring (TDM)	Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.			0	18	15	18

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Tinnitus	Ear and labyrinth disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected15 at risk EG0010 affected18 at risk
Eye discharge	Eye disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected15 at risk EG0010 affected18 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected15 at risk EG0011 affected18 at risk
Colonic polyp	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected15 at risk EG0010 affected18 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0005 affected15 at risk EG0013 affected18 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected15 at risk EG0011 affected18 at risk
Flatulence	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected15 at risk EG0010 affected18 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected15 at risk EG0010 affected18 at risk
Nausea	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0002 affected15 at risk EG0011 affected18 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected15 at risk EG0010 affected18 at risk
Vomiting	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected15 at risk EG0014 affected18 at risk
Adverse drug reaction	General disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected15 at risk EG0010 affected18 at risk
Fatigue	General disorders	MedDRA 10.1	Systematic Assessment	EG0003 affected15 at risk EG0010 affected18 at risk
Feeling abnormal	General disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected15 at risk EG0010 affected18 at risk
Pyrexia	General disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected15 at risk EG0010 affected18 at risk
Bronchitis	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0001 affected15 at risk EG0010 affected18 at risk
Conjunctivitis infective	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0001 affected15 at risk EG0010 affected18 at risk
Gastroenteritis	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 affected15 at risk EG0011 affected18 at risk
Genital herpes	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 affected15 at risk EG0011 affected18 at risk
Infection	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0001 affected15 at risk EG0010 affected18 at risk
Nasopharyngitis	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 affected15 at risk EG0011 affected18 at risk
Oral candidiasis	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0001 affected15 at risk EG0010 affected18 at risk
Oropharyngeal candidiasis	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 affected15 at risk EG0011 affected18 at risk
Rash pustular	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 affected15 at risk EG0011 affected18 at risk
Sinusitis	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0001 affected15 at risk EG0010 affected18 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0001 affected15 at risk EG0010 affected18 at risk
Vaginal infection	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 affected15 at risk EG0011 affected18 at risk
Blood amylase increased	Investigations	MedDRA 10.1	Systematic Assessment	EG0001 affected15 at risk EG0010 affected18 at risk
Blood cholesterol increased	Investigations	MedDRA 10.1	Systematic Assessment	EG0001 affected15 at risk EG0010 affected18 at risk
Blood triglycerides increased	Investigations	MedDRA 10.1	Systematic Assessment	EG0001 affected15 at risk EG0012 affected18 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA 10.1	Systematic Assessment	EG0001 affected15 at risk EG0010 affected18 at risk
Lipase increased	Investigations	MedDRA 10.1	Systematic Assessment	EG0001 affected15 at risk EG0010 affected18 at risk
Dyslipidaemia	Metabolism and nutrition disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected15 at risk EG0010 affected18 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected15 at risk EG0010 affected18 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected15 at risk EG0010 affected18 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected15 at risk EG0010 affected18 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected15 at risk EG0011 affected18 at risk
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected15 at risk EG0010 affected18 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 10.1	Systematic Assessment	EG0002 affected15 at risk EG0010 affected18 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected15 at risk EG0010 affected18 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 10.1	Systematic Assessment	EG0002 affected15 at risk EG0010 affected18 at risk
Melanocytic naevus	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.1	Systematic Assessment	EG0001 affected15 at risk EG0010 affected18 at risk
Dizziness	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected15 at risk EG0012 affected18 at risk
Headache	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected15 at risk EG0011 affected18 at risk
Depression	Psychiatric disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected15 at risk EG0011 affected18 at risk
Nightmare	Psychiatric disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected15 at risk EG0011 affected18 at risk
Sleep disorder	Psychiatric disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected15 at risk EG0011 affected18 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected15 at risk EG0011 affected18 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected15 at risk EG0011 affected18 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected15 at risk EG0011 affected18 at risk
Erythema nodosum	Skin and subcutaneous tissue disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected15 at risk EG0010 affected18 at risk
Heat rash	Skin and subcutaneous tissue disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected15 at risk EG0011 affected18 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected15 at risk EG0010 affected18 at risk
Pruritus generalised	Skin and subcutaneous tissue disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected15 at risk EG0010 affected18 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 10.1	Systematic Assessment	EG0002 affected15 at risk EG0011 affected18 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected15 at risk EG0011 affected18 at risk
Subcutaneous nodule	Skin and subcutaneous tissue disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected15 at risk EG0010 affected18 at risk
Vitiligo	Skin and subcutaneous tissue disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected15 at risk EG0010 affected18 at risk
Hot flush	Vascular disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected15 at risk EG0010 affected18 at risk
Hypertension	Vascular disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected15 at risk EG0010 affected18 at risk

The study was terminated early due to low patient enrollment, and, therefore, no analysis was performed on the primary and secondary endpoints

Certain Agreements

ID	Term
D015658	HIV Infections

Ancestor Terms

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
C107201	tipranavir
D019438	Ritonavir
D000077560	Enfuvirtide
D000077592	Maraviroc
D000068898	Raltegravir Potassium

Ancestor Terms

ID	Term
D013844	Thiazoles
D013457	Sulfur Compounds
D009930	Organic Chemicals
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D010446	Peptide Fragments
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D015700	HIV Envelope Protein gp41
D014760	Viral Fusion Proteins
D050576	Membrane Fusion Proteins
D008565	Membrane Proteins
D011506	Proteins
D015488	HIV Antigens
D000956	Antigens, Viral
D014764	Viral Proteins
D054299	env Gene Products, Human Immunodeficiency Virus
D015686	Gene Products, env
D012191	Retroviridae Proteins
D054298	Human Immunodeficiency Virus Proteins
D014759	Viral Envelope Proteins
D015678	Viral Structural Proteins
D000941	Antigens
D001685	Biological Factors
D003510	Cyclohexanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D014230	Triazoles
D011760	Pyrrolidinones
D011759	Pyrrolidines