Two-year safety and tolerability study of enfuvertide use in salvage therapy of Thai HIV-1 experienced cases.

OBJECTIVE: To assess safety and tolerability of enfuvirtide, an antiretroviral, in Thai patients with advanced HIV-1 disease who have received antiretroviral treatment and failed on regimens that contain at least one of each antiretroviral (ARV) classes (PIs, NRTIs, and NNRTIs), or who have intolerance to previous antiretroviral regimens. MATERIAL AND METHOD: An open-label non-comparative study of enfuvirtide used in salvage regimens along with the backbone antiretroviral therapy of choice in Thai HIV-1 experienced cases that have been treated with at least one of each available ARV classes. RESULTS: Twenty-three patients were recruited from five participating centers. Seventeen patients (74%) completed 96 weeks of the treatment. Six patients prematurely withdrew from the present study in which three expired from HIV related complications, two withdrew consents, and one from adverse event. The most common adverse event is injection site reactions, which occurred in 22 patients. The manifestations and intensity varied from rash, erythema, edema, pain, induration, and bleeding at the injection sites, to inflammatory nodules. Most of the patients tolerated the treatment well. Enfuvirtide administered along with other antiretroviral combination provided a good control of the disease. CONCLUSION: Enfuvirtide was well tolerated by Thai patients who participated in the present study. The adverse events did not compromise the patient compliance.

Factors associated with tuberculin skin test reactivity among HIV-infected people in Bangkok.

INH preventive therapy (IPT) has been shown in several randomized controlled trials to reduce the risk of developing active TB in tuberculin skin test (TST) or purified protein derivative (PPD) positive HIV infected individuals. Detection of latent tuberculosis by TST and determination of factors associated with the PPD positivity in HIV-infected persons are important for the targeting of chemoprophylaxis. Six hundred asymptomatic and early symptomatic HIV-infected subjects attending the AIDS Clinic of the Chulalongkorn University Hospital, Bangkok, Thailand were enrolled in two randomized clinical trials of chemoprophylaxis against TB from December 1994 to December 1996. The availability of baseline characteristics, including TST reactivity, among these participants enabled a cross-sectional analysis of factors associated with PPD positivity. The results showed that 117 (19.5%) were PPD positive and 483 (80.5%) were PPD negative with ages 18-65 years (median 29 years). HIV exposure category was 46.2%, 34.5%, and 6.7% for heterosexual contact, commercial sex work, and homosexual and bisexual male contact respectively. The median CD4 cell count was 315/mm3 (range, 5-1,074/mm3). HIV exposure category and CD4 cell count were significantly associated with PPD status. Homosexual/bisexual contact had 3 times higher risk of PPD positivity than heterosexual contact (adjusted OR=2.9; 95% CI, 1.4-6.1) and risk of PPD positivity was higher among patients with CD4 cell counts of 200-500/ mm3 (adjusted OR=1.8; 95% CI, 1.0-3.1) and above 500/mm3 (adjusted OR=3.4; 95% CI, 1.7-6.7) when compared to patients with CD4 cell counts of less than 200/mm3. The HIV-infected persons in Bangkok with homosexual/bisexual contact are at higher risk for latent TB. Population-based tuberculin screening without accompanying HIV testing cannot be used to estimate the prevalence of actual latent TB in a population where HIV infection is widespread, such as in Thailand.

Antiretroviral Drug-Associated Oral Lichenoid Reaction in HIV Patient: A Case Report.

Antiretroviral therapy has changed the course of HIV disease and improved quality of life in HIV patients. Incidence of an oral lichenoid drug reaction induced by zidovudine is not common. Once it occurs, it affects a patient's well being, in particular their oral functions. Here we report the first case of a 34-year-old Thai man with painful erosive lesions involving the lip and buccal mucosa. Treatment with topical fluocinolone acetonide 0.1% alleviated the patient's oral pain, but it was not until the subsequent withdrawal of zidovudine that the patient showed improvement and resolution of the lesions. Long-term follow-up was useful in the management of this patient, and no recurrence of the lesion was found during 21-month follow-up in this patient.

Systematic review of clinical trials evaluating low doses of stavudine as part of antiretroviral treatment.

Stavudine is a nucleoside analogue used for the treatment of HIV-1 infection, as part of highly active antiretroviral treatment. In developing countries, stavudine is used widely, owing to low cost and inclusion in generic fixed-dose combinations. In developed countries, stavudine is now rarely used, although it is highly effective. This is because newer drugs show lower rates of mitochondrial toxicities, such as lipoatrophy, peripheral neuropathy and lactic acidosis. In the development of stavudine, there was evidence that a dosage of 20-30 mg b.i.d. was effective, but the 40-mg b.i.d. dose gained regulatory approval. This review analyses the clinical trials conducted before and after the regulatory approval of stavudine, and shows that the dose of 30 mg b.i.d. has equivalent antiviral efficacy (given the caveats of meta-analysis), with some evidence of lower rates of peripheral neuropathy and lipoatrophy. With limited resources for HIV-1 treatment in developing countries, and only 25% of eligible patients receiving highly active antiretroviral treatment, low-cost treatment options such as stavudine still need to be pursued, if safety can be improved by dose optimisation.