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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 (\
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enfuvirtide + OB (Not Randomized) | Experimental | Participants will receive enfuvirtide 90 milligram (mg) twice daily (b.i.d.) and OB as per investigator's discretion for 28 weeks during induction period. After induction period participants not meeting the randomization criteria will receive enfuvirtide 90 mg b.i.d and OB for next 24 weeks (up to Week 52). |
|
| Enfuvirtide + OB (Randomized) | Experimental | Participants will receive enfuvirtide 90 mg b.i.d. and OB as per investigator's discretion for 28 weeks during induction period. After induction period participants meeting the randomization criteria will be randomized to receive enfuvirtide 90 mg b.i.d. and OB for next 24 weeks (up to Week 52). |
|
| OB alone (Randomized) | Experimental | Participants will receive enfuvirtide 90 mg b.i.d. and OB as per investigator's discretion for 28 weeks during induction period. After induction period participants meeting the randomization criteria will be randomized to receive OB alone for next 24 weeks (up to Week 52). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enfuvirtide | Drug | Participants will receive 90 mg enfuvirtide subcutaneously (SC) b.i.d. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of randomized participants without virologic failure and with a viral load < 50 copies/mL at Week 52 | Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Number of participants who complied with enfuvirtide and OB treatments as measured by pharmacokinetic score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aix-en-Provence | 13616 | France | ||||
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|
| Optimized background antiretroviral regimen (OB) | Drug | 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. |
|
| Weeks 2, 4, 8, and 24 |
| 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 |
| Change from baseline in viral load | Baseline up to Week 52 or premature withdrawal |
| Proviral deoxyribonucleic acid (DNA) level | Day 0 (inclusion), Weeks 28, and 52 or premature withdrawal |
| Time to reappearance of viral load above 50 copies/mL in randomized participants | 52 weeks |
| 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 |
| 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 |
| 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 |
| 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 |
| 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) |
| 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 |
| 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) |
| Angers |
| 49933 |
| France |
| Annecy | 74011 | France |
| Argenteuil | 95107 | France |
| Auch | 32008 | France |
| Aulnay-sous-Bois | 93600 | France |
| Avignon | 84902 | France |
| Basse-terre | 97100 | France |
| Besançon | 25030 | France |
| Bobigny | 93009 | France |
| Bordeaux | 33000 | France |
| Bordeaux | 33076 | France |
| Boulogne | 62321 | France |
| Bourg-en-Bresse | 01012 | France |
| Caen | 14033 | France |
| Carpentras | 84200 | France |
| Cayenne | 97300 | France |
| Cayenne | 97306 | France |
| Colmar | 68024 | France |
| Corbeil-Essonnes | 91106 | France |
| Créteil | 94000 | France |
| Fort-de-france | 97261 | France |
| Garches | 92380 | France |
| Kourou | 97487 | France |
| La Roche-sur-Yon | 85025 | France |
| Lagny-sur-Marne | 77405 | France |
| Levallois-Perret | 92309 | France |
| Lyon | 69317 | France |
| Lyon | 69437 | France |
| Mantes-la-Jolie | 78200 | France |
| Marseille | 13006 | France |
| Marseille | 13274 | France |
| Marseille | 13385 | France |
| Marseille | 13915 | France |
| Matoury | 97351 | France |
| Mâcon | 71000 | France |
| Montpellier | 34295 | France |
| Nantes | 44035 | France |
| Nice | 06202 | France |
| Niort | 79021 | France |
| Nîmes | 30029 | France |
| Orléans | 45100 | France |
| Paris | 75010 | France |
| Paris | 75015 | France |
| Paris | 75018 | France |
| Paris | 75571 | France |
| Paris | 75651 | France |
| Paris | 75674 | France |
| Paris | 75743 | France |
| Paris | 75970 | France |
| Pau | 64046 | France |
| Perpignan | 66046 | France |
| Pessac | 33600 | France |
| Pointe à Pitre | 97159 | France |
| Pontoise | 95303 | France |
| Quimper | 29000 | France |
| Rennes | 35033 | France |
| Rouen | 73031 | France |
| Saint-Denis | 93202 | France |
| Saint-Denis | 97400 | France |
| Saint-Dizier | 52115 | France |
| Saint-Pierre | 97448 | France |
| Strasbourg | 67091 | France |
| Suresnes | 92150 | France |
| Toulon | 83000 | France |
| Toulouse | 31052 | France |
| Toulouse | 31059 | France |
| Tours | 37044 | France |
| Valenciennes | 59322 | France |
| Vandœuvre-lès-Nancy | 54511 | France |
| Villejuif | 94804 | France |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| 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 |
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| ID | Term |
|---|---|
| D000077560 | Enfuvirtide |
| 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 |
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