Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This 2 arm study will assess the efficacy and safety of a new regimen of Fuzeon
+ optimized background antiretroviral treatment, in Fuzeon-naive HIV-1 infected patients with virological failure. Eligible patients will be randomized to recei ve either new optimized treatment alone, or optimized treatment + Fuzeon 90mg s.
c. twice daily, to determine the effect of 3 month induction with Fuzeon.It will be possible for a patient to receive several additional 3 month periods with F uzeon, in the case of new virological failure. The anticipated time on study tre atment is 3-12 months, and the target sample size is <100 individuals.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| enfuvirtide [Fuzeon] | Drug | 90mg sc bid |
| |
| Optimized background ARV therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with plasma viral load <50 copies/mL | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| CD4 count, virological responders, time to virological failure, number of Fuzeon 'sequences'/patient, AEs, ADEs, injection site reactions. | Throughout study |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aulnay-sous-Bois | 93600 | France | ||||
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
As prescribed |
|
| Basse-terre |
| 97100 |
| France |
| Bordeaux | 33000 | France |
| Boulogne | 62321 | France |
| Caen | 14033 | France |
| Colmar | 68024 | France |
| Fort-de-france | 97261 | France |
| Garches | 92380 | France |
| La Roche-sur-Yon | 85925 | France |
| Le Kremlin-Bicêtre | 91275 | France |
| Levallois-Perret | 92309 | France |
| Lyon | 69317 | France |
| Marseille | 13006 | France |
| Nantes | 44035 | France |
| Nice | 06202 | France |
| Nîmes | 30029 | France |
| Paris | 75010 | France |
| Paris | 75571 | France |
| Paris | 75651 | France |
| Paris | 75674 | France |
| Paris | 75970 | France |
| Pessac | 33600 | France |
| Pointe à Pitre | 97159 | France |
| Poitiers | 86021 | France |
| Pontoise | 95303 | France |
| Rouen | 73031 | France |
| Saint-Denis | 97400 | France |
| Saint-Pierre | 97448 | France |
| Toulouse | 31052 | France |
| Tourcoing | 59208 | 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 |
Not provided
Not provided
| 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 |
Not provided
Not provided