---
title: Fuzeon Viral Decay Pilot Study
nct_id: NCT00334022
overall_status: COMPLETED
phase: NA
sponsor: Canadian Immunodeficiency Research Collaborative
study_type: INTERVENTIONAL
primary_condition: HIV-1
countries: Canada
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00334022.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00334022"
ct_last_update_post_date: 2012-06-05
last_seen_at: "2026-05-12T06:23:04.186Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Fuzeon Viral Decay Pilot Study

**Official Title:** 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

**NCT ID:** [NCT00334022](https://clinicaltrials.gov/study/NCT00334022)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 18
- **Lead Sponsor:** Canadian Immunodeficiency Research Collaborative
- **Collaborators:** Hoffmann-La Roche
- **Conditions:** HIV-1
- **Start Date:** 2006-02
- **Completion Date:** 2010-01
- **CT.gov Last Update:** 2012-06-05

## Brief Summary

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).

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 60 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Did not receive enfuvirtide** (PLACEBO_COMPARATOR) — patients were randomized to either receive enfuviratide or not receive it
- **enfuvirtide** (ACTIVE_COMPARATOR) — enfuvirtide 1ml BID

## Interventions

- **enfuvirtide** (DRUG) — 1ml BID

## Primary Outcomes

- **The change of proviral HIV-1 DNA in both purified resting and activated CD4 T cells from baseline to month 6.** _(time frame: 6 months)_ — The change of proviral HIV-1 DNA in both purified resting and activated CD4 T cells from baseline to month 6.

## Secondary Outcomes

- **To determine the change of proviral HIV-1 DNA from baseline to month 3** _(time frame: 3 months)_
- **To determine the change of proviral HIV-1 DNA from months 6 to 9 after the enfurvitide has been stopped for 3 months in the treatment arm** _(time frame: 9 months)_
- **To quantify plasma HIV (limit of detection 2 copies/ml of plasma)** _(time frame: 9 months)_
- **To quantify cell associated HIV RNA (unspliced and multiply spliced) in resting and activated CD4+ T cells** _(time frame: 9 months)_
- **To determine the decay characteristics of HIV in resting CD4+ T cells by quantitative co-culture assays** _(time frame: 9 months)_
- **To determine the half-life of HIV in resting CD4+ T cells** _(time frame: 9months)_
- **To carry out phylogenetic analysis of HIV in the plasma, resting, and activated CD4+ T cell compartments** _(time frame: 9 months)_
- **To quantify the amount of HIV in gastrointestinal-associated lymphoid tissue (GALT) by quantitative co-culture assays (as part of a sub-study - see GALT sub-study)** _(time frame: 9 months)_

## Locations (1)

- Maple Leaf Medical Clinic, Toronto, Ontario, Canada

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.maple leaf medical clinic|toronto|ontario|canada` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT00334022*  
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