Abstract

Six hundred eighty HIV-infected infants and children aged 2 to 19 years who require Pneumocystis carinii pneumonia (PCP) prophylaxis will be enrolled in this study nationwide. Subjects will be randomized to one of two arms, trimethoprim-sulfamethoxazole (TMP/SMX) or atovaquone plus azithromycin. Subjects will be evaluated for safety and tolerance of the study drugs. Cross-over to alternative study drug regimen will occur for either arm if a serious treatment-related toxicity or serious bacterial infection endpoint is observed. Patients will be followed for two years. Intensive monitoring of subjects will occur for the first 6 months, during which time the subjects will be monitored on a regular basis for adverse events. The primary objectives of this study are 1) to determine the comparability of azithromycin plus atovaquone to TMP/SMX in the prevention of serious bacterial infections; and, 2) to determine and compare the long-term safety and tolerance of atovaquone plus azithromycin versus TMP/SMX. Enrollment has just begun for this protocol.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR006192-03
Application #
5225534
Study Section
Project Start
Project End
Budget Start
Budget End
Support Year
3
Fiscal Year
1996
Total Cost
Indirect Cost

  Publications

Lieberman, Richard; Kranzler, Henry R; Levine, Eric S et al. (2018) Examining the effects of alcohol on GABAA receptor mRNA expression and function in neural cultures generated from control and alcohol dependent donor induced pluripotent stem cells. Alcohol 66:45-53
Usmani, Saad; Choquette, Linda; Bona, Robert et al. (2018) Transient bacteremia induced by dental cleaning is not associated with infection of central venous catheters in patients with cancer. Oral Surg Oral Med Oral Pathol Oral Radiol 125:286-294
Moscufo, Nicola; Wakefield, Dorothy B; Meier, Dominik S et al. (2018) Longitudinal microstructural changes of cerebral white matter and their association with mobility performance in older persons. PLoS One 13:e0194051
Jin, Lingling; Liu, Yi; Sun, Fanyue et al. (2017) Three novel ANO5 missense mutations in Caucasian and Chinese families and sporadic cases with gnathodiaphyseal dysplasia. Sci Rep 7:40935
Lieberman, Richard; Kranzler, Henry R; Levine, Eric S et al. (2017) Examining FKBP5 mRNA expression in human iPSC-derived neural cells. Psychiatry Res 247:172-181
Santos-Cortez, Regie Lyn P; Hu, Ying; Sun, Fanyue et al. (2017) Identification of ASAH1 as a susceptibility gene for familial keloids. Eur J Hum Genet 25:1155-1161
Liu, Yaling; Dutra, Eliane H; Reichenberger, Ernst J et al. (2016) Dietary phosphate supplement does not rescue skeletal phenotype in a mouse model for craniometaphyseal dysplasia. J Negat Results Biomed 15:18
Lieberman, Richard; Armeli, Stephen; Scott, Denise M et al. (2016) FKBP5 genotype interacts with early life trauma to predict heavy drinking in college students. Am J Med Genet B Neuropsychiatr Genet 171:879-87
Litt, Mark D; Duffy, Valerie; Oncken, Cheryl (2016) Cigarette smoking and electronic cigarette vaping patterns as a function of e-cigarette flavourings. Tob Control 25:ii67-ii72
Rash, Carla J; Burki, Madison; Montezuma-Rusca, Jairo M et al. (2016) A retrospective and prospective analysis of trading sex for drugs or money in women substance abuse treatment patients. Drug Alcohol Depend 162:182-9

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