| June 18, 2007 |
| May 13, 2009 |
| |
| |
| Number and percentage of patients with HIV RNA <50 copies/mL [ Time Frame: Week 12 and Week 38 ] [ Designated as safety issue: No ] |
| Number and percentage of patients with HIV RNA <50 copies/mL at week 12, and at week 38. |
| Complete list of historical versions of study NCT00488059 on ClinicalTrials.gov Archive Site |
| Mean change in HIV RNA and CD4 from baseline; number and percentage of patients with HIV RNA <=50 copies/mL and <400 copies/mL; number and percentage of patients with >=1 log decline in HIV RNA from baseline. SAEs, ISRs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ] |
| Efficacy: At multiple time points : mean change in HIV RNA and CD4 from baseline; no. and % of patients with HIV RNA <=50 copies/mL,and <400 copies/mL; no. & % of patients with >=1 log decline in HIV RNA from baseline. Safety:SAEs, ISRs, lab parameters. |
| |
| AMICI Study: A Study of Fuzeon (Enfuvirtide) With an Integrase Inhibitor Plus Optimized Background in Treatment-Experienced HIV-1 Infected Patients. |
| An Open Label Study Evaluating the Antiviral Activity and Safety of Fuzeon in Triple-Class Experienced HIV-1 Infected Patients Changing Their Therapy to a Standard of Care Regimen Which Includes Initiating an Integrase Inhibitor in an Expanded Access Program Plus Optimized Background |
This 2 arm study will evaluate the efficacy and safety of Fuzeon with an integrase inhibitor in an expanded access program plus optimized background in HIV-1 infected patients naive to Fuzeon and an integrase inhibitor. In the first cohort phase of the study, eligible patients will receive Fuzeon 90mg sc b.i.d. until confirmation of response (min/max = 8/16 weeks). In the second, randomised comparator phase of the study, responders will be randomized to receive Fuzeon either 90mg sc b.i.d. or 180mg qd for a further 24 weeks. Non-responders and virological failures will be terminated from the study. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. |
| |
| Phase IV |
| Interventional |
| Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
| HIV Infections |
- Drug: enfuvirtide [Fuzeon]
90mg sc bid
- Drug: Optimized ARV background
As prescribed
- Drug: Integrase inhibitor
As prescribed
- Drug: enfuvirtide [Fuzeon]
180mg sc qd
|
- 1: Experimental
Interventions:
- Drug: enfuvirtide [Fuzeon]
- Drug: Optimized ARV background
- Drug: Integrase inhibitor
- 2: Experimental
Interventions:
- Drug: Optimized ARV background
- Drug: Integrase inhibitor
- Drug: enfuvirtide [Fuzeon]
|
| |
| |
| Completed |
| 30 |
| February 2009 |
|
Inclusion Criteria:
- adult patients, >=18 years of age;
- HIV-1 infection;
- triple class treatment-experienced, Fuzeon- and integrase-inhibitor naive;
- GSS>=3; nucleosides excluded.
Exclusion Criteria:
- adverse clinical or laboratory experience >ACTG Grade 4;
- untreated infection, intercurrent illness, drug toxicity or other condition contraindicating an antiretroviral regimen;
- malignancy requiring chemotherapy or radiotherapy.
|
| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States, Puerto Rico |
| |
| NCT00488059 |
| Clinical Trials, Study Director, Hoffmann-La Roche |
| ML20837 |
| Hoffmann-La Roche |
| Trimeris |
| Study Director: |
Clinical Trials |
Hoffmann-La Roche |
|
|
| Hoffmann-La Roche |
| May 2009 |
