Tuberculosis and Human Immunodeficiency Virus (HIV) Immune Reconstitution Syndrome Trial (THIRST) (NCT00851630) | Clinical Trial Compass
CompletedPhase 4
Tuberculosis and Human Immunodeficiency Virus (HIV) Immune Reconstitution Syndrome Trial (THIRST)
Tanzania70 participantsStarted 2004-06
Plain-language summary
The purpose of this study is twofold: (1) to assess the feasibility and safety of fixed dose combination zidovudine/lamivudine/abacavir in HIV infected subjects with tuberculosis in a resource-limited setting, and (2) to assess the impact of delayed versus early initiation strategies for fixed dose combination zidovudine/lamivudine/abacavir on the rate of tuberculosis-associated immune reconstitution inflammatory syndromes.
Who can participate
Age range13 Years
SexALL
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Inclusion Criteria:
* HIV Infection is documented by rapid HIV test or any licensed enzyme-linked immunosorbent assay (ELISA) test kit and confirmed with a different sample.
* Men or women admitted to Kibongoto or Marangu Hospitals with (a) recent (within 56 days) smear positive tuberculosis (pulmonary or extrapulmonary,) (b)total lymphocyte count \<1,200/mm3, and (c) less than 14 days of antituberculous therapy.
* Antiretroviral naive with the exception of regimens used to prevent mother-to-infant transmission of HIV during pregnancy.
* The following laboratory values obtained within 45 days prior to study entry: absolute neutrophil count (ANC) \>=700/mm³, hemoglobin \> 8 g/dL in women; \>9 g/dL in men, serum creatinine \<= 1.5 times upper limits of normal, AST \<5 times upper limits of normal.
* For all women of reproductive potential (who have not reached menopause or undergone hysterectomy, bilateral oophorectomy, or tubal ligation), a negative urine pregnancy test within 48 hours of to study.
* All subjects must agree not to participate in a conception process (e.g., active attempt to become pregnant or to impregnate) and if participating in sexual activity that could lead to pregnancy, the female subject/male partner must use condoms (male or female) without a spermicidal agent.
* Not intending to relocate out of area for the duration of study participation.
* Willingness of subject to adhere to follow up schedule.
* Men and women \>= age 13.
* Ability and willingness …