Phase 4
Completed N=23
A Study of Enfuvirtide (Fuzeon) in Participants With Advanced Human Immunodeficiency Virus (HIV) Infection
Source: ClinicalTrials.gov NCT02582983 ↗Enrolled (actual)
23
Serious AEs
26.1%
Results posted
Jul 2016
Primary outcomePrimary: Number of Participants With Serious Adverse Events (SAEs) — 6 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 This can indicate results are unpublished — a known publication-bias signal.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 study assessed the safety and tolerability of enfuvirtide in participants with advanced HIV genotype 1 (HIV-1) disease. Eligible participants who failed treatment with regimens containing at least one product from each anti-retroviral class, or had experienced intolerance to previous anti-retroviral regimens received enfuvirtide, 90 milligrams (mg) subcutaneously (SC) twice daily (BID) as long as there were no enfuvirtide related treatment limiting toxicities and participants benefited from study treatment as per investigator's discretion. The anticipated time on study treatment was based on the commercial availability of enfuvirtide in Thailand, and the target sample size was 30 individuals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Serious Adverse Events (SAEs) |
6 | — |
| PRIMARY Number of Participants With Premature Withdrawal Due to Adverse Events |
1 | — |
Eligibility Criteria
Inclusion Criteria
- Individuals at least 16 years of age infected with HIV-1
- CD4 lymphocyte count less than equal to ( =) 10,000 copies/mL while on highly active antiretroviral therapy (HAART)
- Genotypic or phenotypic resistance and/or treatment-limiting toxicity on previous antiretroviral regimens
Exclusion Criteria
- Evidence of ongoing alcohol and/or drug or substance abuse
- Prior non-adherence to antiretroviral treatment regimens
- Evidence of active, untreated opportunistic infection, intercurrent illness, drug toxicity or any other condition.
Data sourced from ClinicalTrials.gov (NCT02582983). 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.