Factors associated with screening failure and study withdrawal in multidrug-resistant TB.

SETTING: Multidrug-resistant TB (MDR-TB) clinical trial in Lima, Peru and Cape Town, South Africa.OBJECTIVE: To identify baseline factors associated with screening failure and study withdrawal in an MDR-TB clinical trial.DESIGN: We screened patients for a randomized, blinded, Phase II trial which assessed culture conversion over the first 6 months of treatment with varying doses of levofloxacin plus an optimized background regimen (ClinicalTrials.gov: NCT01918397). We identified factors for screening failure and study withdrawal using Poisson regression to calculate prevalence ratios and Cox proportional hazard regression to calculate hazard ratios. We adjusted for factors with P < 0.2.RESULTS: Of the 255 patients screened, 144 (56.5%) failed screening. The most common reason for screening failure was an unsuitable resistance profile on sputum-based molecular susceptibility testing (n = 105, 72.9%). No significant baseline predictors of screening failure were identified in the multivariable model. Of the 111 who were enrolled, 33 (30%) failed to complete treatment, mostly for non-adherence and consent withdrawal. No baseline factors predicted study withdrawal in the multivariable model.CONCLUSION: No baseline factors were independently associated with either screening failure or study withdrawal in this secondary analysis of a MDR-TB clinical trial.

The global distribution of human immunodeficiency virus type 2 (HIV-2) infection.

We reviewed published reports of infection with human immunodeficiency virus type 2 (HIV-2) to provide a picture of its geographic distribution, pathogenicity, modes of transmission, and risk to the blood supply. Since the first reports in 1986, 627 HIV-2-seropositive persons have been reported; 604 of these were in natives of West Africa. Acquired immunodeficiency syndrome (AIDS) had developed in 42 patients, while 8 patients had AIDS-related complex. Transmission by sexual intercourse was the usual reported mode of spread. The modes of transmission of HIV-2 are thought to be the same as those for HIV-1, but perinatal transmission and transmission by sharing of needles among intravenous drug abusers have not yet been reported. The virus has not been identified in blood donors in the United States or West Germany, but two HIV-2-infected blood donors were reported in France. Further epidemiologic studies are needed to define the spectrum of disease, modes of transmission, and risk of HIV-2 to the blood supply.