---
title: A Study of Fuzeon (Enfuvirtide) With an Integrase Inhibitor Plus Optimized Background in Treatment-Experienced HIV-1 Infected Patients
nct_id: NCT00488059
overall_status: TERMINATED
phase: PHASE4
sponsor: Hoffmann-La Roche
study_type: INTERVENTIONAL
primary_condition: HIV Infections
countries: United States, Puerto Rico
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00488059.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00488059"
ct_last_update_post_date: 2011-07-22
last_seen_at: "2026-05-12T06:58:13.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Study of Fuzeon (Enfuvirtide) With an Integrase Inhibitor Plus Optimized Background in Treatment-Experienced HIV-1 Infected Patients

**Official Title:** A Multicenter, Open-label Study Evaluating the Antiviral Activity and Safety of Enfuvirtide (ENF) Once Daily (QD) or Twice Daily (BID) in Triple-class Experienced HIV-1 Infected Patients Changing Their Therapy to a Standard of Care (SOC) Regimen That Includes Initiating Raltegravir Plus an Optimized Background (OB) Antiviral Regimen

**NCT ID:** [NCT00488059](https://clinicaltrials.gov/study/NCT00488059)

## Key Facts

- **Status:** TERMINATED
- **Why Stopped:** This study was terminated early due to poor enrollment.
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 29
- **Lead Sponsor:** Hoffmann-La Roche
- **Collaborators:** Trimeris
- **Conditions:** HIV Infections
- **Start Date:** 2007-06
- **Completion Date:** 2008-10
- **CT.gov Last Update:** 2011-07-22

## Brief Summary

This 2-arm study evaluated the efficacy and safety of Fuzeon with an integrase inhibitor in an expanded access program plus an optimized background antiviral regimen (AVR) in HIV-1 infected patients naive to Fuzeon and an integrase inhibitor. In the first cohort phase of the study (Phase I), eligible patients received Fuzeon 90 mg subcutaneously (SC) twice daily until confirmation of response (min/max = 8/16 weeks). In Phase II, the randomised comparator phase of the study, responders were randomized to receive Fuzeon either 90 mg SC twice a day or 180 mg SC once a day for a further 16 weeks. Non-responders and virological failures were terminated from the study. The anticipated time on study treatment was 3-9 months, and the target sample size was 210 individuals.

## Eligibility

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

```
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
```

## Arms

- **Phase I** (EXPERIMENTAL) — Phase 1: ENF 90mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® \[raltegravir\] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).
- **Phase II** (EXPERIMENTAL) — In the randomized comparator Phase II of the trial- (Day II-1 through Week II-16): Virologic responders confirmed HIV-1 RNA ≤50 copies/mL from Phase I were randomized to 1 of 2 treatment arms of

(Phase II Arm A: Phase I then ENF 90mg SC BID): ENF 90 mg SC BID + RAL 400 mg PO BID + OB with at least 1 fully active ARV agent excluding NRTIs or (Phase II Arm B: Phase I then ENF 180mg SC QD): ENF 180 mg SC once daily (QD) + RAL 400 mg PO BID + OB with at least 1 fully active ARV agent excluding NRTIs.

## Interventions

- **enfuvirtide [Fuzeon]** (DRUG) — 90 mg SC twice daily
- **Optimized background ARV** (DRUG) — As prescribed
- **Integrase inhibitor** (DRUG) — As prescribed
- **enfuvirtide [Fuzeon]** (DRUG) — 180 mg SC once daily

## Primary Outcomes

- **Number of Patients in Phase I of the Study With a Confirmed HIV-1 RNA Viral Load ≤ 50 Copies/mL** _(time frame: Between Week I-4 and Week I-12 of Phase I of the study)_ — Virologic responders were defined as patients who had an initial HIV-1 RNA assessment \<= 50 copies/mL during Phase I at any visit between Week I-4 and Week I-12 and a confirmatory viral load assessment ≤ 50 copies/mL at the next visit (Week I-8 to Week II-16)
- **Number of Patients in Phase II of the Study With HIV-1 RNA ≤ 50 Copies/mL at Week II-16** _(time frame: Week II-16)_

## Secondary Outcomes

- **Virologic Response Over Time in Phase I of the Study** _(time frame: Weeks 4, 8 & 12)_
- **HIV-1 RNA Viral Load Change From Baseline in Phase I of the Study** _(time frame: Baseline and Weeks 4, 8, 12 & LOCF)_
- **Virologic Response Over Time in Phase II of the Study** _(time frame: Weeks II-4, 8, 12 & 16)_
- **CD4+ Lymphocyte Count Change From Baseline** _(time frame: Phase I Baseline and Phase II Weeks II-1, 12, 16, and LOCF)_
- **Percentage of Patients With Ongoing Injection Site Reactions (ISRs)** _(time frame: Phase I and II)_

## Locations (43)

- Hobson City, Alabama, United States
- Phoenix, Arizona, United States
- Los Angeles, California, United States
- Los Angeles, California, United States
- Los Angeles, California, United States
- Los Angeles, California, United States
- Modesto, California, United States
- Stanford, California, United States
- Washington D.C., District of Columbia, United States
- Fort Lauderdale, Florida, United States
- Fort Lauderdale, Florida, United States
- Fort Myers, Florida, United States
- Miami, Florida, United States
- Miami Beach, Florida, United States
- North Palm Beach, Florida, United States
- Orlando, Florida, United States
- Plantation, Florida, United States
- Port Saint Lucie, Florida, United States
- Safety Harbor, Florida, United States
- South Miami, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Atlanta, Georgia, United States
- Macon, Georgia, United States
- Chicago, Illinois, United States
- Silver Spring, Maryland, United States
- Boston, Massachusetts, United States
- Kansas City, Missouri, United States
- St Louis, Missouri, United States
- Newark, New Jersey, United States
- Briarcliff Manor, New York, United States
- New York, New York, United States
- Rochester, New York, United States
- The Bronx, New York, United States
- Allentown, Pennsylvania, United States
- Philadelphia, Pennsylvania, United States
- Reading, Pennsylvania, United States
- Dallas, Texas, United States
- Fort Worth, Texas, United States
- Houston, Texas, United States
- Annandale, Virginia, United States
- Ponce, Puerto Rico
- Santurce, Puerto Rico

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — 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.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.|hobson city|alabama|united states` — added _(2026-05-12)_
- `locations.|phoenix|arizona|united states` — added _(2026-05-12)_
- `locations.|los angeles|california|united states` — added _(2026-05-12)_
- `locations.|modesto|california|united states` — added _(2026-05-12)_
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- `locations.|silver spring|maryland|united states` — added _(2026-05-12)_
- `locations.|boston|massachusetts|united states` — added _(2026-05-12)_
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---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00488059.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00488059*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*