Trial | NCT00334022  Report issue

Title

Fuzeon Viral Decay Pilot Study
A Pilot Randomized Controlled Trial of Adding Enfuvirtide to Standard Combination Antiretroviral Therapy in HIV-infected Individuals With Full Virologic Suppression to Further Suppress Proviral HIV DNA

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Indication/Condition

    HIV-1

  • Study Participants

    18
In order to better understand the source(s) and the mechanism(s) of HIV persistence and to potentially lead to further suppression of HIV from viral reservoirs, we propose to examine the effect of co-administration of enfuvirtide, an entry inhibitor of HIV, on diminution of the size of the viral reservoir in infected individuals who are receiving effective antiviral therapy for extended periods of time (> 5 years).
Study Started
Feb 28
2006
Primary Completion
Jul 31
2007
Study Completion
Jan 31
2010
Last Update
Jun 05
2012
Estimate

Drug enfuvirtide

1ml BID

Did not receive enfuvirtide Placebo Comparator

patients were randomized to either receive enfuviratide or not receive it

enfuvirtide Active Comparator

enfuvirtide 1ml BID

Criteria 

Inclusion Criteria:

Patient must be HIV infected
Patient must be > 18 years old
Patient must be taking standard combination antiretroviral therapy with 2-3 NRTIs and 1-2 PIs or a NNRTIs for at least five years
Patient must have a viral load < 50 copies/mL (using the standard available methods of detection) during the entire time on standard combination antiretroviral therapy except for initial fall of viral load
Patient must have a CD4 count above 400 cells/mm3 in last 3 months
Female patient must agree to use two methods of birth control or abstinence during the period of the study
Patient has to have signed full informed consent

Exclusion Criteria:

Patient who would have difficulty participating in a trial due to non-adherence or substance abuse
Patient who have taken mono or dual antiretroviral therapy
Patient who have had a viral load > 50 copies/mL on any antiretroviral regimen

Patient with any of the following abnormal laboratory test results in screening:

Hemaglobin < 100 g/L
Neutrophil count < 750 cells/uL
Platelet count < 50,000 cells/L
AST or ALT > 5X the upper limit of normal
Creatinine > 250 umol/L
Patient with a malignancy
Patient with other significant underlying disease (non-HIV) that might impinge upon disease progression or death
Patient with an active AIDS-defining illnesses in the past six months
Patients who are pregnant
No Results Posted