Efficacy, and Safety Study of Optimized Background Antiretroviral Regimen (OB) in Combination With Enfuvirtide in the Treatment-Experienced Participants With Human Immunodeficiency Virus-1 (HIV-1) Infection

PHASE3CompletedINTERVENTIONAL
Enrollment

84

Participants

Timeline

Start Date

December 31, 2004

Primary Completion Date

March 31, 2008

Study Completion Date

March 31, 2008

Conditions
HIV Infections
Interventions
DRUG

Enfuvirtide

Participants will receive 90 mg enfuvirtide subcutaneously (SC) b.i.d.

DRUG

Optimized background antiretroviral regimen (OB)

Participants will receive OB (nucleoside and or non-nucleoside reverse transcriptase inhibitor and protease inhibitor) as per investigator's discretion. Protocol does not specify any particular OB drugs.

Trial Locations (71)

13006

Marseille

13274

Marseille

13385

Marseille

13616

Aix-en-Provence

13915

Marseille

14033

Caen

25030

Besançon

29000

Quimper

30029

Nîmes

31052

Toulouse

31059

Toulouse

32008

Auch

33000

Bordeaux

33076

Bordeaux

33600

Pessac

34295

Montpellier

35033

Rennes

37044

Tours

44035

Nantes

45100

Orléans

49933

Angers

52115

Saint-Dizier

54511

Vandœuvre-lès-Nancy

59322

Valenciennes

62321

Boulogne

64046

Pau

66046

Perpignan

67091

Strasbourg

68024

Colmar

69317

Lyon

69437

Lyon

71000

Mâcon

73031

Rouen

74011

Annecy

75010

Paris

75015

Paris

75018

Paris

75571

Paris

75651

Paris

75674

Paris

75743

Paris

75970

Paris

77405

Lagny-sur-Marne

78200

Mantes-la-Jolie

79021

Niort

83000

Toulon

84200

Carpentras

84902

Avignon

85025

La Roche-sur-Yon

91106

Corbeil-Essonnes

92150

Suresnes

92309

Levallois-Perret

92380

Garches

93009

Bobigny

93202

Saint-Denis

93600

Aulnay-sous-Bois

94000

Créteil

94804

Villejuif

95107

Argenteuil

95303

Pontoise

97100

Basse-terre

97159

Pointe à Pitre

97261

Fort-de-france

97300

Cayenne

97306

Cayenne

97351

Matoury

97400

Saint-Denis

97448

Saint-Pierre

97487

Kourou

01012

Bourg-en-Bresse

06202

Nice

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT02733419 - Efficacy, and Safety Study of Optimized Background Antiretroviral Regimen (OB) in Combination With Enfuvirtide in the Treatment-Experienced Participants With Human Immunodeficiency Virus-1 (HIV-1) Infection | Biotech Hunter | Biotech Hunter