A Study to Evaluate the Safety and Efficacy of Adding Enf... | NCT00487188

Label	Type	Description	Intervention Names
ENF + HAART	Experimental	Participants received Enfuvirtide (ENF) 90 mg administered by subcutaneous injection twice a day for up to 48 weeks in addition to an oral highly active antiretroviral treatment (HAART) regimen for up to 48 weeks.	Drug: Enfuvirtide Drug: Highly active antiretroviral treatment (HAART)
HAART	Active Comparator	Participants received an oral highly active antiretroviral treatment (HAART) regimen, consisting of 3-5 antivirals for up to 48 weeks.	Drug: Highly active antiretroviral treatment (HAART)

Name	Type	Description	Arm Group Labels	Other Names
Enfuvirtide	Drug	90 mg subcutaneous injection twice a day	ENF + HAART

Measure	Description	Time Frame
Number of Participants With Viral Suppression: HIV-1 RNA < 50 Copies/mL During the Induction Phase	Participants whose viral load achieved suppression (HIV-1 RNA < 50 copies/mL) at Week 24 at the latest, confirmed at Week 28 (2 consecutive assessments ≥ 28 days apart) were defined as responders. Patients who discontinued the study or did not respond to assigned treatment by week 28 were considered as non-responders.	From Baseline 1 to Week 28

Measure	Description	Time Frame
Time to Achieving HIV-1 RNA < 50 Copies/mL During the Induction Phase	The time to achieving HIV-1 RNA <50 copies/mL was counted from Baseline 1 until the first of the two consecutive <50 copies/mL measurements. Patients who discontinued from the study or patients who did not have confirmed virological response by week 28 were classed as non-responders and censored at Week 24.	Baseline 1 until Week 28.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

HIV-1 infected adults >=18 years of age;
currently on antiretroviral (ARV) therapy;
previously treated with 2 or 3 different antiretroviral classes;
HIV-1 Ribonucleic acid (RNA) >=1,000 copies/mL;
Cluster differentiation antigen four (CD4) lymphocyte count >=200 cells/mm^3;
females of childbearing potential must be willing to use a reliable form of effective barrier contraception for the duration of the study and for 30 days after the last dose of study drug.

Exclusion Criteria:

history of prior use of enfuvirtide or T-1249;
women who are pregnant, breastfeeding or planning to become pregnant during the study;
active, untreated opportunistic infection;
patients on treatment interruption, or patients interrupting ARV therapy within 4 weeks of screening or during the screening period for reasons either than toxicity management.

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

PubMed Identifier	Type	Citation	Retractions
18782780	Derived	Clotet B, Capetti A, Soto-Ramirez LE, Gatell JM, Rowell L, Salgo M, Schapiro JM. A randomized, controlled study evaluating an induction treatment strategy in which enfuvirtide was added to an oral, highly active antiretroviral therapy regimen in treatment-experienced patients: the INTENSE study. J Antimicrob Chemother. 2008 Dec;62(6):1374-8. doi: 10.1093/jac/dkn377. Epub 2008 Sep 8.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	ENF + HAART	Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment during the Induction and Maintenance Phase for up to 48 weeks of treatment.
FG001	HAART

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

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

Number of Participants With Viral Suppression: HIV-1 RNA < 50 Copies/mL During the Induction Phase

Participants whose viral load achieved suppression (HIV-1 RNA < 50 copies/mL) at Week 24 at the latest, confirmed at Week 28 (2 consecutive assessments ≥ 28 days apart) were defined as responders. Patients who discontinued the study or did not respond to assigned treatment by week 28 were considered as non-responders.

Intent-to-Treat Population 1 (ITT1) population (patients evaluable for efficacy in the induction phase)

Posted

Number

Participants

From Baseline 1 to Week 28

ID	Title	Description
OG000	ENF+HAART	Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment.
OG001	HAART	Participants received highly active antiretroviral treatment.

Units	Counts
Participants	OG00031 OG00116

Title

Denominators

Categories

Title	Measurements
	OG00020 OG0018

Secondary

Time to Achieving HIV-1 RNA < 50 Copies/mL During the Induction Phase

The time to achieving HIV-1 RNA <50 copies/mL was counted from Baseline 1 until the first of the two consecutive <50 copies/mL measurements.

Patients who discontinued from the study or patients who did not have confirmed virological response by week 28 were classed as non-responders and censored at Week 24.

Intent-to-Treat Population 1 (ITT1) population (patients evaluable for efficacy in the induction phase).

Posted

Median

Inter-Quartile Range

days

Baseline 1 until Week 28.

ID	Title	Description
OG000	ENF+HAART	Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment.
OG001	HAART	Participants received highly active antiretroviral treatment.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Viral Suppression HIV-1 RNA < 400 Copies/mL During the Induction Phase

Participants whose viral load achieved suppression (HIV-1 RNA < 400 copies/mL) by Week 24 at the latest, confirmed at Week 28 (2 consecutive assessments ≥ 28 days apart) were defined as responders. Patients who discontinued the study or did not respond to assigned treatment by Week 28 were considered as non-responders.

ITT1 population (patients evaluable for efficacy in the induction phase)

Posted

Number

Participants

From Baseline 1 to Week 28

ID	Title	Description
OG000	ENF+HAART	Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment.
OG001	HAART	Participants received highly active antiretroviral treatment.

Units	Counts
Participants	OG000

Secondary

Change From Baseline to Week 24 in Viral Load

Change from Baseline in log10 HIV-1 RNA at Week 24. Least squares means were calculated from an analysis of covariance (ANCOVA) model with treatment, a flag variable "removed ENF at re-randomization" and Baseline viral load as independent variables.

Intent-to-Treat Population 1 (ITT1) population (patients evaluable for efficacy in the Induction Phase). Baseline values were carried forward (i.e. the change from baseline set to zero) for patients with missing data at week 24 or who withdrew prior to the week 24 time window.

Posted

Least Squares Mean

95% Confidence Interval

log10 copies/mL

Baseline and Week 24

ID	Title	Description
OG000	ENF+HAART	Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment.
OG001	HAART	Participants received highly active antiretroviral treatment.

Units	Counts
Participants

Secondary

Change From Baseline to Week 24 in Cluster Differentiation Antigen Four Positive (CD4+) Cell Counts

Change from Baseline in CD4+ Cell Counts at Week 24. Least squares means were calculated from an ANCOVA model with treatment as an independent variable.

Posted

Least Squares Mean

95% Confidence Interval

cells/mm^3

Baseline and Week 24

ID	Title	Description
OG000	ENF+HAART	Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment.
OG001	HAART	Participants received highly active antiretroviral treatment.

Units	Counts
Participants	OG000

Secondary

Percentage of Induction Phase Participants With Viral Load < 50 Copies/mL at 48 Weeks

The percentage of participants from the Induction Phase who maintained HIV-1 RNA < 50 Copies/mL at Week 48. Patients who discontinued from the study, rebounded to ≥ 50 copies/mL (i.e., had two consecutive readings ≥ 50 copies/mL), had missing data or had virological failure by Week 48 were classed as non-responders.

Induction Phase Intent-to-Treat Population 1 (ITT1).

Posted

Number

percentage of participants

Week 48

ID	Title	Description
OG000	ENF+HAART	Participants received enfuvirtide (ENF) 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment (HAART) in the Induction Phase. In the Maintenance Phase, participants either continued to receive ENF+HAART or HAART alone. This group contains all patients who were randomized to ENF+HAART at BL1 and follows the patients throughout 48 weeks, regardless of which arm they were randomized to at BL2.
OG001	HAART	Participants received highly active antiretroviral treatment during both the Induction and Maintenance Phase.

Units	Counts

Secondary

Percentage of Maintenance Phase Participants With Viral Load < 50 Copies/mL at 48 Weeks

The percentage of participants from the Maintenance Phase who maintained HIV-1 RNA < 50 copies/mL at Week 48. Patients who discontinued from the study, rebounded to ≥ 50 copies/mL (i.e., had two consecutive readings ≥ 50 copies/mL), had missing data or had virological failure by Week 48 were classed as non-responders.

Maintenance Phase Intent-to-Treat Population 2 (ITT2).

Posted

Number

percentage of participants

Week 48

ID	Title	Description
OG000	ENF+HAART	Participants received enfuvirtide (ENF) 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment (HAART) in the Induction Phase. In the Maintenance Phase, participants either continued to receive ENF+HAART or HAART alone. This group contains all patients who entered the Maintenance phase from the ENF+HAART Induction phase, regardless of which arm they were randomized to at BL2.
OG001	HAART	Participants received highly active antiretroviral treatment during both the Induction and Maintenance Phase.

Units	Counts
Participants

Secondary

Change From Baseline to Week 48 in Cluster Differentiation Antigen Four Positive (CD4) Cell Counts

Change from Baseline in CD4 Cell Counts at Week 48. Least squares means were calculated from an ANCOVA model with treatment and baseline CD4 count as independent variables.

Intent-to-Treat Population 2 (ITT2) population (patients evaluable for efficacy in the Maintenance Phase). Baseline values were carried forward (i.e. the change from baseline set to zero) for patients with missing data at week 48 or who withdrew prior to the week 48 time window.

Posted

Least Squares Mean

95% Confidence Interval

cells/mm^3

Baseline 1 and Week 48

ID	Title	Description
OG000	ENF+HAART	Participants received enfuvirtide (ENF) 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment (HAART) in the Induction Phase. In the Maintenance Phase, participants either continued to receive ENF+HAART or HAART alone. This group contains all patients who entered the Maintenance phase from the ENF+HAART Induction phase, regardless of which arm they were randomized to at BL2.
OG001	HAART	Participants received highly active antiretroviral treatment during both the Induction and Maintenance Phase.

Secondary

Time to Loss of Viral Response During the Maintenance Phase

The time to loss of viral response (defined as HIV-1 RNA <50 copies/mL) was counted from Baseline 2 until the first of two consecutive ≥50 copies/mL measurements.

Only patients who were qualified for entering the Maintenance Phase were included in the analysis.

Maintenance Phase Intent-to-Treat Population 2 (ITT2)

Posted

Median

Inter-Quartile Range

days

From Baseline 2 to Week 48.

ID	Title	Description
OG000	ENF+HAART	Participants received enfuvirtide (ENF) 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment (HAART) in the Induction Phase. In the Maintenance Phase, participants either continued to receive ENF+HAART or HAART alone. This group contains all patients who entered the Maintenance phase from the ENF+HAART Induction phase, regardless of which arm they were randomized to at BL2.
OG001	HAART	Participants received highly active antiretroviral treatment during both the Induction and Maintenance Phase.

Units	Counts
Participants

Secondary

Time to Virological Failure During the Maintenance Phase

Time to virological failure (defined as HIV-1 RNA ≥ 400 copies/mL) was counted from Baseline 2 until the first of the two consecutive ≥400 copies/mL measurements.

Only patients who were qualified for entering the Maintenance Phase were included in the analyses.

Maintenance Phase Intent-to-Treat Population 2 (ITT2)

Posted

Median

Inter-Quartile Range

days

From Baseline 2 to Week 48.

ID	Title	Description
OG000	ENF+HAART	Participants received enfuvirtide (ENF) 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment (HAART) in the Induction Phase. In the Maintenance Phase, participants either continued to receive ENF+HAART or HAART alone. This group contains all patients who entered the Maintenance Phase from the ENF+HAART Induction Phase, regardless of which arm they were randomized to at BL2.
OG001	HAART	Participants received highly active antiretroviral treatment during both the Induction and Maintenance Phase.

Units	Counts
Participants

Secondary

Number of Participants With Virological Failure During the Maintenance Phase

Virological failure was defined by 2 consecutive HIV-1 RNA values ≥ 400 copies/mL during the Maintenance Phase.

Maintenance Phase Intent-to-Treat Population 2 (ITT2)

Posted

Number

Participants

From Baseline 2 to Week 48.

ID	Title	Description
OG000	ENF+HAART	Participants received enfuvirtide (ENF) 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment (HAART) in the Induction Phase. In the Maintenance Phase, participants either continued to receive ENF+HAART or HAART alone. This group contains all patients who entered the Maintenance Phase from the ENF+HAART Induction Phase, regardless of which arm they were randomized to at BL2.
OG001	HAART	Participants received highly active antiretroviral treatment during both the Induction and Maintenance Phase.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Maintaining CD4+ Count During the Maintenance Phase

Maintenance of CD4+ count defined as having greater than or equal to 200 cells/mm^3 at Baseline 2 (BL2) and greater than or equal to 200 cells/mm^3 at Week 48.

Maintenance Phase ITT2 population with a Baseline 2 CD4+ count of greater than or equal to 200 cells/mm^3.

Posted

Number

percentage of participants

Baseline 2 to Week 48.

ID	Title	Description
OG000	ENF + HAART	Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment during the Induction and Maintenance Phase for up to 48 weeks of treatment.
OG001	HAART	Participants received highly active antiretroviral treatment during the Induction and Maintenance Phase for up to 48 weeks of treatment.
OG002	HAART (ENF Removed)	Participants who had received ENF + HAART during the Induction Phase and responded to treatment by Week 24 continued to receive HAART alone during the Maintenance Phase, for a total of 48 weeks of treatment.

Secondary

Percentage of Participants With Improvement in CD4+ Count During the Maintenance Phase

Improvement of CD4+ count defined as having from 100 to less than 200 CD4+ cells/mm^3 at Baseline 2 (BL2) and greater than or equal to 200 cells/mm^3 at Week 48.

Maintenance Phase ITT2 population with a Baseline 2 CD4+ count of ≥100 to <200 cells/mm^3.

Posted

Number

percentage of participants

Baseline 2 to Week 48.

ID	Title	Description
OG000	ENF + HAART	Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment during the Induction and Maintenance Phase for up to 48 weeks of treatment.
OG001	HAART	Participants received highly active antiretroviral treatment during the Induction and Maintenance Phase for up to 48 weeks of treatment.
OG002	HAART (ENF Removed)	Participants who had received ENF + HAART during the Induction Phase and responded to treatment by Week 24 continued to receive HAART alone during the Maintenance Phase, for a total of 48 weeks of treatment.

Secondary

Number of Participants With Adverse Events (AEs) During the Induction Phase

A serious AE (SAE) is an event which: results in death, is life-threatening, disabling or incapacitating; is a congenital anomaly in the offspring of a patient who received study drug; requires or prolongs inpatient hospitalization; jeopardizes the patient or require medical or surgical intervention to prevent one of the outcomes above; any Grade 4 laboratory value considered by the investigator clinically significant or that requires an action; any injection site reaction that meets SAE criteria above. Non-serious AEs reported include pneumonia and non-serious AEs that led to discontinuation.

Safety Population

Posted

Number

participants

Start of the study treatment until the end of the Induction Phase (Week 12 to Week 32)

ID	Title	Description
OG000	ENF+HAART	Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment.
OG001	HAART	Participants received highly active antiretroviral treatment.

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Induction: ENF+HAART	During the Induction Phase participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment for a maximum of 32 weeks.	3	29	9	29
EG001	Induction Phase: HAART	During the Induction Phase participants received highly active antiretroviral treatment for a maximum of 32 weeks.	3	18	11	18
EG002	Maintenance Phase: ENF + HAART	During the Maintenance Phase, participants who had received ENF+HAART and who responded to treatment during the Induction Phase continued to receive enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment for up to 48 weeks of total treatment.	2	10	2	10
EG003	Maintenance Phase: HAART (ENF Removed)	During the Maintenance Phase, participants who had received ENF+HAART and who responded to treatment during the Induction Phase continued to receive HAART alone during the Maintenance Phase, for up to a total of 48 weeks treatment.	3	9	4	9
EG004	Maintenance Phase: HAART	During the Maintenance Phase, participants who had received HAART alone and who responded to treatment during the Induction Phase continued to receive highly active antiretroviral treatment for up to 48 weeks of total treatment.	0	8	3	8

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
PAROTITIS	Infections and infestations	MedDRA (10.1)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected18 at risk EG0020 affected10 at risk EG0030 affected9 at risk EG0040 affected8 at risk
POSTOPERATIVE WOUND INFECTION	Infections and infestations	MedDRA (10.1)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected18 at risk EG0020 affected10 at risk EG003
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA (10.1)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected18 at risk EG0020 affected10 at risk EG003
VOMITING	Gastrointestinal disorders	MedDRA (10.1)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected18 at risk EG0020 affected10 at risk EG003
ANAEMIA	Blood and lymphatic system disorders	MedDRA (10.1)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected18 at risk EG0020 affected10 at risk EG003
INJECTION SITE REACTION	General disorders	MedDRA (10.1)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected18 at risk EG0020 affected10 at risk EG003
HEPATIC FAILURE	Hepatobiliary disorders	MedDRA (10.1)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected18 at risk EG0020 affected10 at risk EG003
RHABDOMYOLYSIS	Musculoskeletal and connective tissue disorders	MedDRA (10.1)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected18 at risk EG0020 affected10 at risk EG003
RENAL FAILURE	Renal and urinary disorders	MedDRA (10.1)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected18 at risk EG0020 affected10 at risk EG003
INFECTION	Infections and infestations	MedDRA (10.1)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected18 at risk EG0020 affected10 at risk EG003
PNEUMONIA	Infections and infestations	MedDRA (10.1)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected18 at risk EG0021 affected10 at risk EG003
HEPATIC FUNCTION ABNORMAL	Hepatobiliary disorders	MedDRA (10.1)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected18 at risk EG0021 affected10 at risk EG003
ANAL CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.1)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected18 at risk EG0020 affected10 at risk EG003
CALCULUS URETERIC	Renal and urinary disorders	MedDRA (10.1)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected18 at risk EG0020 affected10 at risk EG003
RESPIRATORY DISTRESS	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected18 at risk EG0021 affected10 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
DIARRHOEA	Gastrointestinal disorders	MedDRA (10.1)	Systematic Assessment	EG0002 affected29 at risk EG0015 affected18 at risk EG0020 affected10 at risk EG0030 affected9 at risk EG0040 affected8 at risk
ABDOMINAL DISTENSION	Gastrointestinal disorders	MedDRA (10.1)	Systematic Assessment	EG0001 affected29 at risk EG0012 affected18 at risk EG0020 affected10 at risk EG003
VOMITING	Gastrointestinal disorders	MedDRA (10.1)	Systematic Assessment	EG0002 affected29 at risk EG0011 affected18 at risk EG0020 affected10 at risk EG003
NAUSEA	Gastrointestinal disorders	MedDRA (10.1)	Systematic Assessment	EG0001 affected29 at risk EG0011 affected18 at risk EG0020 affected10 at risk EG003
ODYNOPHAGIA	Gastrointestinal disorders	MedDRA (10.1)	Systematic Assessment	EG0001 affected29 at risk EG0011 affected18 at risk EG0020 affected10 at risk EG003
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	MedDRA (10.1)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected18 at risk EG0020 affected10 at risk EG003
DRY MOUTH	Gastrointestinal disorders	MedDRA (10.1)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected18 at risk EG0020 affected10 at risk EG003
FLATULENCE	Gastrointestinal disorders	MedDRA (10.1)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected18 at risk EG0020 affected10 at risk EG003
CELLULITIS	Infections and infestations	MedDRA (10.1)	Systematic Assessment	EG0002 affected29 at risk EG0010 affected18 at risk EG0020 affected10 at risk EG003
PHARYNGITIS	Infections and infestations	MedDRA (10.1)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected18 at risk EG0021 affected10 at risk EG003
BRONCHITIS	Infections and infestations	MedDRA (10.1)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected18 at risk EG0020 affected10 at risk EG003
FOLLICULITIS	Infections and infestations	MedDRA (10.1)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected18 at risk EG0020 affected10 at risk EG003
GINGIVAL ABSCESS	Infections and infestations	MedDRA (10.1)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected18 at risk EG0020 affected10 at risk EG003
NASOPHARYNGITIS	Infections and infestations	MedDRA (10.1)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected18 at risk EG0020 affected10 at risk EG003
TRANSAMINASES INCREASED	Investigations	MedDRA (10.1)	Systematic Assessment	EG0000 affected29 at risk EG0012 affected18 at risk EG0020 affected10 at risk EG003
PLATELET COUNT DECREASED	Investigations	MedDRA (10.1)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected18 at risk EG0020 affected10 at risk EG003
HEADACHE	Nervous system disorders	MedDRA (10.1)	Systematic Assessment	EG0001 affected29 at risk EG0011 affected18 at risk EG0020 affected10 at risk EG003
DIZZINESS	Nervous system disorders	MedDRA (10.1)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected18 at risk EG0020 affected10 at risk EG003
EPISTAXIS	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected18 at risk EG0020 affected10 at risk EG003
PULMONARY CONGESTION	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected18 at risk EG0020 affected10 at risk EG003
RASH	Skin and subcutaneous tissue disorders	MedDRA (10.1)	Systematic Assessment	EG0001 affected29 at risk EG0011 affected18 at risk EG0020 affected10 at risk EG003
THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA (10.1)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected18 at risk EG0020 affected10 at risk EG003
TINNITUS	Ear and labyrinth disorders	MedDRA (10.1)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected18 at risk EG0020 affected10 at risk EG003
CHEST PAIN	General disorders	MedDRA (10.1)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected18 at risk EG0020 affected10 at risk EG003
HEPATIC FAILURE	Hepatobiliary disorders	MedDRA (10.1)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected18 at risk EG0020 affected10 at risk EG003
DRUG HYPERSENSITIVITY	Immune system disorders	MedDRA (10.1)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected18 at risk EG0020 affected10 at risk EG003
ANOREXIA	Metabolism and nutrition disorders	MedDRA (10.1)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected18 at risk EG0020 affected10 at risk EG003
MUSCULOSKELETAL CHEST PAIN	Musculoskeletal and connective tissue disorders	MedDRA (10.1)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected18 at risk EG0020 affected10 at risk EG003
INSOMNIA	Psychiatric disorders	MedDRA (10.1)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected18 at risk EG0020 affected10 at risk EG003
CONSTIPATION	Gastrointestinal disorders	MedDRA (10.1)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected18 at risk EG0020 affected10 at risk EG003
DYSPHAGIA	Gastrointestinal disorders	MedDRA (10.1)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected18 at risk EG0021 affected10 at risk EG003
TOOTHACHE	Gastrointestinal disorders	MedDRA (10.1)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected18 at risk EG0020 affected10 at risk EG003
COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Systematic Assessment	EG0001 affected29 at risk EG0010 affected18 at risk EG0021 affected10 at risk EG003
ABSCESS JAW	Infections and infestations	MedDRA (10.1)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected18 at risk EG0020 affected10 at risk EG003
INFLUENZA	Infections and infestations	MedDRA (10.1)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected18 at risk EG0020 affected10 at risk EG003
ONYCHOMYCOSIS	Infections and infestations	MedDRA (10.1)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected18 at risk EG0021 affected10 at risk EG003
PNEUMONIA BACTERIAL	Infections and infestations	MedDRA (10.1)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected18 at risk EG0020 affected10 at risk EG003
HYPERCHOLESTEROLAEMIA	Metabolism and nutrition disorders	MedDRA (10.1)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected18 at risk EG0020 affected10 at risk EG003
HYPERTRIGLYCERIDAEMIA	Metabolism and nutrition disorders	MedDRA (10.1)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected18 at risk EG0020 affected10 at risk EG003
PAIN	General disorders	MedDRA (10.1)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected18 at risk EG0020 affected10 at risk EG003
CONJUNCTIVITIS	Eye disorders	MedDRA (10.1)	Systematic Assessment	EG0000 affected29 at risk EG0011 affected18 at risk EG0020 affected10 at risk EG003
SKIN INJURY	Injury, poisoning and procedural complications	MedDRA (10.1)	Systematic Assessment	EG0000 affected29 at risk EG0010 affected18 at risk EG0021 affected10 at risk EG003

Facility	Status	City	State	ZIP	Country	Contacts
		Cleveland	Ohio	44109	United States

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
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

ID	Title	Description
BG000	ENF+HAART	Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment.
BG001	HAART	Participants received highly active antiretroviral treatment.
BG002	Total	Total of all reporting groups