HIV Infections, Peripheral Neuropathy
Conditions
Brief summary
To evaluate the safety and efficacy of pregabalin in reducing neuropathic pain associated with HIV neuropathy
Interventions
DRUGpregabalin
75mg BID, titrated up to 300mg according to individual response and tolerability
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participation in the preceding A0081066 double-blind trial met the entry criteria for that trial and completed A0081066 study through visit 7
Exclusion criteria
* Experienced serious adverse event during the A0081066 trial that was considered related or possibly related to study medication by the investigator or sponsor * non-compliant during A0081066 trial * clinically significant or unstable medical condition both HIV-related and non-HIV related including but not limited to, cardiac, pulmonary or hepatorenal disease that, in the opinion of the investigator, would compromise participation in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Visual Analogue Scale (VAS) Pain Scores | Baseline, Week 4, Week 8, Week 12, and Endpoint | Pain scores were assessed on a 100 mm Visual Analogue Scale (VAS); scores range from 0= no pain to 100= worse pain. Subjects assessed their pain during the last week. Endpoint = last non-missing observation carried forward after Baseline visit. |
Countries
Puerto Rico, United States
Participant flow
Recruitment details
With completion of A0081066 (NCT00232141), subjects had option of initiating treatment with pregabalin under open-label conditions for 3 months in A0081095, an open-label extension trial. Treatment in A0081095 was initiated on the evening of the subjects' Visit 7/Termination Visit in A0081066. A0081095 was conducted in the United States.
Participants by arm
| Arm | Count |
|---|---|
| Pregabalin Subjects who met all eligibility criteria initiated open-label treatment at 150 mg/day (75 mg BID). Further adjustments of total daily dose within the dose range 150 to 600 mg/day (BID) were permitted throughout the study to optimize pain control and minimize adverse events (AEs). | 220 |
| Total | 220 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 6 |
| Overall Study | Lost to Follow-up | 6 |
| Overall Study | Protocol Violation | 11 |
| Overall Study | Withdrawal by Subject | 7 |
Baseline characteristics
| Characteristic | Pregabalin |
|---|---|
| Age, Continuous | 48.3 years STANDARD_DEVIATION 7.8 |
| Sex: Female, Male Female | 42 Participants |
| Sex: Female, Male Male | 178 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 82 / — |
| serious Total, serious adverse events | 10 / — |
Outcome results
Primary
Mean Visual Analogue Scale (VAS) Pain Scores
Pain scores were assessed on a 100 mm Visual Analogue Scale (VAS); scores range from 0= no pain to 100= worse pain. Subjects assessed their pain during the last week. Endpoint = last non-missing observation carried forward after Baseline visit.
Time frame: Baseline, Week 4, Week 8, Week 12, and Endpoint
Population: The full analysis set was defined as all subjects who met all eligibility criteria and took at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pregabalin | Mean Visual Analogue Scale (VAS) Pain Scores | Baseline (n=203) | 38.61 score on scale | Standard Deviation 27.1 |
| Pregabalin | Mean Visual Analogue Scale (VAS) Pain Scores | Week 4 (n=204) | 30.75 score on scale | Standard Deviation 25.19 |
| Pregabalin | Mean Visual Analogue Scale (VAS) Pain Scores | Week 8 (n=200) | 30.16 score on scale | Standard Deviation 25.78 |
| Pregabalin | Mean Visual Analogue Scale (VAS) Pain Scores | Week 12 (n=207) | 28.95 score on scale | Standard Deviation 26.05 |
| Pregabalin | Mean Visual Analogue Scale (VAS) Pain Scores | Endpoint (n=217) | 29.39 score on scale | Standard Deviation 26.32 |