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

HIV Infections Clinical Trial

Official title:

Open-label, Randomised and Multi-center Study Evaluating the Efficacy and Safety of an Optimised Background Antiretroviral Regimen (OB) Compared to OB Associated With Enfuvirtide in Previously Treated HIV-1 Infected Patients in Virological Success After a 28-week Induction Treatment With Enfuvirtide Plus OB

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02733419
• Other study ID #: ML18242
• Status: Completed
• Phase: Phase 3
• First received: April 5, 2016
• Last updated: April 5, 2016
• Start date: December 2004
• Est. completion date: March 2008

Study information

• Verified date: April 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: French Health Products Safety Agency (AFSSAPS)
• Study type: Interventional

Clinical Trial Summary

This is an open-label, randomized and multi-center study to compare the efficacy and safety of continued enfuvirtide (Fuzeon) plus (+) OB therapy versus OB alone in participants with HIV-1 infection. Participants will receive an initial 28 week induction treatment with enfuvirtide + OB. After 28 weeks participants with a plasma viral load less than or equal to (</=) 400 copies/milliliter (mL) at Week 16 and less than (<) 50 copies/mL at Week 24 will be randomized in the ratio 1:1 to receive either enfuvirtide + OB or OB alone for another 24 weeks (up to Week 52).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participants with HIV-1 infection

• Female participants without any risk of pregnancy

• Participants previously treated with drugs of 2 or 3 different antiretroviral classes

• Participants currently on highly active antiretroviral treatment (HAART) for more than 4 weeks and with a plasma viral load between 1,000 and 300,000 copies of HIV-1 ribonucleic acid per milliliter (RNA/mL)

• Participants with the possibility of potentially effective OB without enfuvirtide, consisting to 2 to 5 drugs, at least two of which are active from at least two different antiretroviral classes

• Cluster of differentiation 4 (CD4) cell count greater than (>) 50 cells/cubic millimeter (mm^3) at screening

• Participants in whom resistance mutations have been detected in reverse transcriptase and/or protease genes

• Enfuvirtide-naive participants

Exclusion Criteria:

• Women of childbearing age not using effective mechanical contraception

• Pregnant or breastfeeding women

• Presence of HIV-2 coinfection

• Participants participating or having participated to another clinical trial during the 30 days prior to selection for this trial

• Participants having previously been treated with enfuvirtide

• Presence active opportunistic infection within 1 month of study entry

• Existence of Grade 4 clinical or laboratory abnormalities

• Cirrhosis or severe hepatic failure

• Uncontrolled diabetes or requiring insulin

• Consumption of alcohol and/or narcotics and/or other substances

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections

Intervention

Drug:
• Enfuvirtide
Participants will receive 90 mg enfuvirtide subcutaneously (SC) b.i.d.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of randomized participants without virologic failure and with a viral load < 50 copies/mL at Week 52		Week 52	No
Secondary	Number of participants with virologic response (viral load < 50 copies/mL, 200 copies/mL, and 400 copies/mL)		Weeks 2, 4, 8, 12, 16, 24, 28, 32, 36, 44, and 52	No
Secondary	Number of participants who complied with enfuvirtide and OB treatments as measured by pharmacokinetic score		Weeks 2, 4, 8, and 24	No
Secondary	Quality of life as assessed by medical outcomes study-HIV (MOS-HIV) questionnaire score		Day 0 (inclusion), Weeks 4, 12, 24, 28, 32, 44, and 52 or premature withdrawal	No
Secondary	Change from baseline in viral load		Baseline up to Week 52 or premature withdrawal	No
Secondary	Proviral deoxyribonucleic acid (DNA) level		Day 0 (inclusion), Weeks 28, and 52 or premature withdrawal	No
Secondary	Time to reappearance of viral load above 50 copies/mL in randomized participants		52 weeks	No
Secondary	Changes from baseline in CD4 and CD8 cell counts		Day -35 (screening), Day 0 (inclusion), Weeks 4, 12, 24, 28, 36, 44, and 52 or premature withdrawal	No
Secondary	Number of virologic failure participants with reverse transcriptase, protease, and coating resistance mutations for plasma HIV-1 RNA and proviral DNA		Day 0 (inclusion) up to Week 52	No
Secondary	Number of participants with cause of virologic failure		Day 0 (inclusion), Weeks 2, 4, 8, 16, 28, 32, 36, 44, and 52 or premature withdrawal	No
Secondary	Number of participants who complied with enfuvirtide treatment, as assessed by counting treatment units returned versus supplied		Weeks 4, 8, 12, 16, 24, 28, 32, 36, 44, and 52	No
Secondary	Number of participants with adverse events		Day 0 (inclusion), Weeks 2, 4, 8, 12, 16, 24, 28, 32, 36, 44, and 52 or premature withdrawal and follow-up (approximately up to 452 days)	No
Secondary	Number of participants with missed treatment doses or injections as assessed by compliance questionnaire		Day 0 (inclusion), Weeks 4, 12, 24, 28, 32, 44, and 52 or premature withdrawal	No
Secondary	Number of participants with injection site reaction		Day 0 (inclusion), Weeks 2, 4, 8, 12, 16, 24, 28, 32, 36, 44, and 52 or premature withdrawal and follow-up (approximately up to 452 days)	No