DRUG
Enfuvirtide
Participants will receive 90 mg enfuvirtide subcutaneously (SC) b.i.d.
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
Status
Completed
Phase
Phase 3
Enrollment
84
Locations
71
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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).
Interventions
Treatment arms and agents.
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.
Timeline
From registration to results.
First posted
Apr 11, 2016
Study start
Dec 2004
Primary completion
Mar 2008
Study completion
Mar 2008
Results posted
Not reported
Registry updated
Apr 11, 2016
Outcomes
What the study measures.
Primary outcomes
Percentage of randomized participants without virologic failure and with a viral load < 50 copies/mL at Week 52
Time frame · Week 52
Secondary outcomes
Number of participants with virologic response (viral load < 50 copies/mL, 200 copies/mL, and 400 copies/mL)
Time frame · Weeks 2, 4, 8, 12, 16, 24, 28, 32, 36, 44, and 52
Number of participants who complied with enfuvirtide and OB treatments as measured by pharmacokinetic score
Time frame · Weeks 2, 4, 8, and 24
Quality of life as assessed by medical outcomes study-HIV (MOS-HIV) questionnaire score
Time frame · Day 0 (inclusion), Weeks 4, 12, 24, 28, 32, 44, and 52 or premature withdrawal
Change from baseline in viral load
Time frame · Baseline up to Week 52 or premature withdrawal
Proviral deoxyribonucleic acid (DNA) level
Time frame · Day 0 (inclusion), Weeks 28, and 52 or premature withdrawal
Time to reappearance of viral load above 50 copies/mL in randomized participants
Time frame · 52 weeks
Changes from baseline in CD4 and CD8 cell counts
Time frame · Day -35 (screening), Day 0 (inclusion), Weeks 4, 12, 24, 28, 36, 44, and 52 or premature withdrawal
Number of virologic failure participants with reverse transcriptase, protease, and coating resistance mutations for plasma HIV-1 RNA and proviral DNA
Time frame · Day 0 (inclusion) up to Week 52
Number of participants with cause of virologic failure
Time frame · Day 0 (inclusion), Weeks 2, 4, 8, 16, 28, 32, 36, 44, and 52 or premature withdrawal
Number of participants who complied with enfuvirtide treatment, as assessed by counting treatment units returned versus supplied
Time frame · Weeks 4, 8, 12, 16, 24, 28, 32, 36, 44, and 52
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
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 locations
71 registered sites.
France. Showing up to 24 locations stored in the fast local snapshot.
Facility not named
Aix-en-Provence, France
Facility not named
Angers, France
Facility not named
Annecy, France
Facility not named
Argenteuil, France
Facility not named
Auch, France
Facility not named
Aulnay-sous-Bois, France
Facility not named
Avignon, France
Facility not named
Basse-terre, France
Facility not named
Besançon, France
Facility not named
Bobigny, France
Facility not named
Bordeaux, France
Facility not named
Bordeaux, France
Facility not named
Boulogne, France
Facility not named
Bourg-en-Bresse, France
Facility not named
Caen, France
Facility not named
Carpentras, France
Facility not named
Cayenne, France
Facility not named
Cayenne, France
Facility not named
Colmar, France
Facility not named
Corbeil-Essonnes, France
Facility not named
Créteil, France
Facility not named
Fort-de-france, France
Facility not named
Garches, France
Facility not named
Kourou, France
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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More studies on Enfuvirtide.
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