Fuzeon Viral Decay Pilot Study

Plain-language summary

This pilot study looks at the effect of enfuvirtide (Fuzeon) on virus levels in patients with HIV (human immunodeficiency virus) infection. HIV patients older than 18 who had been on combination antiretroviral therapy for at least five years and had a low viral load were able to take part. Sponsored by the Canadian Immunodeficiency Research Collaborative, this study had no assigned phase and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Not Applicable

Status

Completed

Sponsor

Canadian Immunodeficiency Research Collaborative

Intervention

enfuvirtide

Start date

2/1/2006

Estimated completion

1/1/2010

Countries

Canada

Related genes

Locations

• Toronto, Canada

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

1. Patient must be HIV infected
2. Patient must be \> 18 years old
3. Patient must be taking standard combination antiretroviral therapy with 2-3 NRTIs and 1-2 PIs or a NNRTIs for at least five years
4. 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
5. Patient must have a CD4 count above 400 cells/mm3 in last 3 months
6. Female patient must agree to use two methods of birth control or abstinence during the period of the study
7. Patient has to have signed full informed consent

Exclusion Criteria:

1. Patient who would have difficulty participating in a trial due to non-adherence or substance abuse
2. Patient who have taken mono or dual antiretroviral therapy
3. Patient who have had a viral load \> 50 copies/mL on any antiretroviral regimen
4. 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
5. Patient with a malignancy
6. Patient with other significant underlying disease (non-HIV) that might impinge upon disease progression or death
7. Patient with an active AIDS-defining illnesses in the past six months
8. Patients who are pregnant