Phase 4
Completed N=140
BLQ Study: A Study of a Protease Inhibitor With Fuzeon (Enfuvirtide) in Treatment-Experienced Patients With HIV-1.
Source: ClinicalTrials.gov NCT00326963 ↗Enrolled (actual)
140
Serious AEs
9.5%
Results posted
Aug 2016
Primary outcomePrimary: Number of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Viral Load <50 Copies/mL — 79; 78 participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This single arm study will evaluate the efficacy, safety and tolerability of a new investigational protease inhibitor (PI) plus background antiretrovirals plus Fuzeon (90mg sc bid) in HIV-1 infected, triple-class treatment-experienced, Fuzeon-naive adults. The new investigational PI will be administered according to the procedures of the early access program in which the patient is enrolled. The anticipated time on study treatment is 3-12 months, and the target sample size is approximately 120 individuals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Viral Load <50 Copies/mL |
79; 78 | — |
| PRIMARY Percentage of Participants With HIV-1 RNA Viral Load <50 Copies/mL |
21.4; 21.4; 48.9; 48.1 | — |
| SECONDARY Number of Participants With HIV-1 RNA Viral Load <50 Copies/mL |
28; 28; 64; 63 | — |
| SECONDARY Percentage of Participants With HIV-1 RNA Viral Load <50 Copies/mL |
21.4; 21.4; 48.9; 48.1 | — |
| SECONDARY Number of Participants With HIV-1 RNA Viral Load <400 Copies/mL |
74; 89; 95; 74; 88; 94 | — |
| SECONDARY Percentage of Participants With HIV-1 RNA Viral Load <400 Copies/mL |
56.5; 67.9; 72.5; 56.5; 67.2; 71.8 | — |
| SECONDARY Change From Baseline in Log 10 Plasma HIV-1 RNA Viral Load |
-2.22; -2.51; -2.61 | — |
| SECONDARY Number of Participants With Any Adverse Event (AE) and Serious Adverse Event (SAE) |
15; 13 | — |
| SECONDARY Change From Baseline in CD4+ Lymphocyte Count |
56; 83; 89 | — |
| SECONDARY Number of Participants Meeting Virologic Failure Criteria |
2; 10; 19; 45 | — |
| SECONDARY Percentage of Participants Meeting Virologic Failure Criteria |
1.5; 7.6; 14.5; 34.4 | — |
| SECONDARY Number of Participants Adhering to Enfuvirtide (ENF) |
108; 108; 108; 119; 98; 98 | — |
| SECONDARY Percentage of Participants Adhering to ENF |
86.4; 86.4; 86.4; 95.2; 86.7; 86.7 | — |
| SECONDARY Number of Participants With 1 or More Injection Site Reactions Meeting the Criteria of an Serious Adverse Event |
— | — |
| SECONDARY Percentage of Participants With 1 or More Injection Site Reactions Meeting the Criteria of an Serious Adverse Event |
— | — |
| SECONDARY Descriptive Summary of ISR Parameters (ie, Severity and Frequency of Pain and Symptoms) by Injection Device Based on an ISR Grading Tool. |
73; 24; 11; 1; 68; 23 | — |
| SECONDARY Number of Participants Discontinuing Study Medication Due to Clinical Adverse Events |
3; 1; 1; 1 | — |
Eligibility Criteria
Inclusion Criteria
- adult patients, >=18 years of age;
- seropositive for HIV-1;
- enrolled in an early access program for a new investigational PI;
- naive to Fuzeon, and the investigational PI;
- treatment-experienced with 3 ARV classes of drug (NRTI, NNRTI and PI).
Exclusion Criteria
- females who are pregnant or breast-feeding;
- evidence of active, untreated opportunistic infection;
- malignancy requiring chemotherapy or radiotherapy.
Data sourced from ClinicalTrials.gov (NCT00326963). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.