HIV Infections
Conditions
Brief 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.
Interventions
DRUGEnfuvirtide
All participants received enfuvirtide 90 mg SC BID until 4 weeks after commercial availability was established in Thailand.
Sponsors
Hoffmann-La Roche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Individuals at least 16 years of age infected with HIV-1 * CD4 lymphocyte count less than equal to (\<=) 100 cells per cubic millimeter (cells/mm\^3) and HIV-1 ribonucleic acid (RNA) viral load greater 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Serious Adverse Events (SAEs) | Up to 28 days after permanent discontinuation of study treatment (approximately 100 weeks) | A serious adverse event is any untoward medical occurrence that at any dose: results in death, or is life-threatening, or requires inpatient hospitalization or prolongation of existing hospitalization, or results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. The term life-threatening in the definition of serious refers to an event in which the patient was at risk of death at the time of the event, not an event which hypothetically might have caused death if it were more severe. |
| Number of Participants With Premature Withdrawal Due to Adverse Events | Up to 96 weeks | — |
Countries
Thailand
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Enfuvirtide Participants received Enfuvirtide 90 mg subcutaneously (SC) twice daily (BID) | 23 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Death | 3 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Enfuvirtide |
|---|---|
| Age, Continuous | 42.17 years STANDARD_DEVIATION 8.56 |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 23 / 23 |
| serious Total, serious adverse events | 6 / 23 |
Outcome results
Primary
Number of Participants With Premature Withdrawal Due to Adverse Events
Time frame: Up to 96 weeks
Population: The analysis population was defined as the number of participants who enrolled in the study and received at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Enfuvirtide | Number of Participants With Premature Withdrawal Due to Adverse Events | 1 participants |
Primary
Number of Participants With Serious Adverse Events (SAEs)
A serious adverse event is any untoward medical occurrence that at any dose: results in death, or is life-threatening, or requires inpatient hospitalization or prolongation of existing hospitalization, or results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. The term life-threatening in the definition of serious refers to an event in which the patient was at risk of death at the time of the event, not an event which hypothetically might have caused death if it were more severe.
Time frame: Up to 28 days after permanent discontinuation of study treatment (approximately 100 weeks)
Population: The analysis population was defined as the number of participants who enrolled in the study and received at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Enfuvirtide | Number of Participants With Serious Adverse Events (SAEs) | 6 participants |