pregabalin and HIV-Infections

This article is a systematic review of data from 2018 to 2020 regarding information from publications on epidemiologic, diagnostic, and therapeutic advancements in human immunodeficiency virus-associated peripheral neuropathy.. The epidemiology/pathology of HIV neuropathy is discussed. Diagnostics includes skin wrinkling-eutectic mixture of local anesthetic test and neurologic examinations. Therapeutic interventions include pharmacologic and nonpharmacologic management as well as self-management strategies. Peripheral neuropathy continues to affect the lives of persons living with HIV. First-line treatment with pregabalin or gabapentin for HIV neuropathic pain has limited data on adequate response. Exercise and self-management strategies may provide benefit in pain reduction. Continuing research on risk factors and biomarkers for HIV-related peripheral neuropathy will be critical for future diagnostic and therapeutic agents.

Topics: Anesthetics, Local; Gabapentin; HIV Infections; Humans; Neuralgia; Neurologic Examination; Pregabalin

Topics: Administration, Cutaneous; Analgesics; Capsaicin; HIV Infections; Humans; Neuralgia; Neuralgia, Postherpetic; Pain Management; Pregabalin; Transdermal Patch; TRPV Cation Channels

A variety of response-adaptive randomization procedures have been proposed in literature assuming binary outcomes. However, the list is not so long for continuous outcomes though many real clinical trials deal with continuous treatment responses. In this paper, we attempt to explore the available procedures together with a comparison of their performances. Some real-life adaptive trial is also reviewed.

Topics: Biostatistics; Clinical Trials, Phase III as Topic; Computer Simulation; Female; HIV Infections; Humans; Infant, Newborn; Infectious Disease Transmission, Vertical; Models, Statistical; Neuralgia, Postherpetic; Pregabalin; Pregnancy; Pregnancy Complications, Infectious; Randomized Controlled Trials as Topic; Statistics, Nonparametric; Zidovudine

The objective of these studies was to assess the efficacy and safety of pregabalin in the treatment of human immunodeficiency virus (HIV)-associated neuropathic pain. Patients with HIV-associated distal sensory polyneuropathy (DSP) were randomized to treatment with flexible-dose pregabalin (150-600 mg/day) or placebo for 17 weeks in a single-blind, placebo lead-in, randomized, double-blind, parallel-group, placebo-controlled multinational trial. The primary efficacy outcome was the change in mean pain score on an 11-point numeric rating scale (NRS) from baseline to study endpoint. Participants who completed this trial were invited to participate in a 6-month open-label extension study with pregabalin. Of the 377 patients enrolled in the randomized controlled trial (pregabalin, n=183; placebo, n=194), 68.4% completed treatment. In the open-label extension, 217 patients were treated and 59.4% completed treatment. Both studies were terminated by the sponsor after a preplanned interim analysis indicated trial futility. At endpoint, the change from baseline in least-squares mean NRS pain scores in the intent-to-treat population was -2.04 for pregabalin versus -2.11 for placebo (P=.709). There were no significant differences between the pregabalin and placebo groups in the secondary efficacy measures. Incidence of adverse events was lower than seen in previous pregabalin studies. Overall, this trial did not show pregabalin to be more efficacious than placebo in treating HIV-associated DSP. Studies such as these, which fail to support their primary hypotheses, may be important in informing the methodology of future trials, especially when novel approaches to limit variability in the control group are included. ClinicalTrials.gov identifiers: NCT01049217 and NCT01145417.

Topics: Adult; Aged; Analgesics; Double-Blind Method; Female; HIV Infections; Humans; Male; Middle Aged; Neuralgia; Pain Measurement; Polyneuropathies; Pregabalin; Single-Blind Method; Treatment Outcome; Young Adult

Pregabalin is effective in several neuropathic pain syndromes. This trial evaluated its efficacy, safety, and tolerability for treatment of painful HIV-associated neuropathy.. This randomized, double-blind, placebo-controlled, parallel-group trial included a 2-week double-blind dose-adjustment (150-600 mg/day BID) phase, a 12-week double-blind maintenance phase, and an optional 3-month open label extension phase. The primary efficacy measure was the mean Numeric Pain Rating Scale (NPRS) score, an 11-point numeric rating scale. Secondary measures included Patient Global Impression of Change (PGIC) and sleep measurements.. Baseline mean NPRS score was 6.93 for patients randomized to pregabalin (n = 151) and 6.72 for those to placebo (n = 151). Pregabalin average daily dosage (SD) was 385.7 (160.3) mg/d. At endpoint, pregabalin and placebo showed substantial reductions in mean NPRS score from baseline: -2.88 vs -2.63, p = 0.3941. Pregabalin had greater improvements in NPRS score relative to placebo at weeks 1 (-1.14 vs -0.69, p = 0.0131) and 2 (-1.92 vs -1.43, p = 0.0393), and at weeks 7 (-3.22 vs -2.53 p = 0.0307) and 8 (-3.33 vs -2.53, p = 0.0156). At all other time points, differences between groups were not significant. Sleep measurements and 7-item PGIC did not differ among treatment groups; however, collapsed PGIC scores showed 82.8% of pregabalin and 66.7% of placebo patients rated themselves in 1 of the 3 "improved" categories (p = 0.0077). Somnolence and dizziness were the most common adverse events with pregabalin.. Pregabalin was well-tolerated, but not superior to placebo in the treatment of painful HIV neuropathy. Factors predicting analgesic response in HIV neuropathy warrant additional research.. This Class II trial showed that pregabalin is not more effective than placebo in treatment of painful HIV neuropathy.

Topics: Adult; Analgesics; Analysis of Variance; Double-Blind Method; Female; Follow-Up Studies; gamma-Aminobutyric Acid; HIV Infections; Humans; Male; Middle Aged; Neuralgia; Pain Measurement; Pregabalin; Retrospective Studies

Topics: Analgesics; Female; HIV Infections; Humans; Male; Neuralgia; Polyneuropathies; Pregabalin