Phase 1 N=14 Phase I Study of Pyrimethamine in Healthy Japanese and Caucasian Subjects
Toxoplasmosis
Primary: Maximum Observed Concentration (Cmax) of Pyrimethamine in Healthy Japanese Male Participants — 430.5 Nanogram per milliliter
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Phase 3 N=399 A Randomized Trial to Prevent Congenital Cytomegalovirus (CMV)
Congenital Cytomegalovirus Infection · Maternal Cytomegalovirus Infection
Primary: Number of Participants With the Composite Primary Outcome — 46; 37 Participants — p=0.42
N/A N=155 Study of the Transmission of Cytomegalovirus (CMV) Infection From Mother to Foetus
Infections, Cytomegalovirus · Cytomegalovirus Infections
Primary: Number of Subjects With Any Cytomegalovirus (CMV) Congenital Infection — 24; 20; 4; 58 Participants
Phase 3 N=87 Short-course Benznidazole Treatment to Reduce Trypanosoma Cruzi Parasitic Load in Women of Reproductive Age
Chagas Disease
Primary: Global PCR (Conventional PCR and Real-time Quantitative PCR) Immediately After the End of Treatment. — 16; 20 Participants
Phase 4 N=956 Evaluating the Safety of Immediate Versus Deferred Isoniazid Preventive Therapy Among HIV-Infected Pregnant Women
HIV Infections · Tuberculosis
Primary: Incidence Rate of Combined Endpoint: Grade 3 or Higher Adverse Events (AEs) Related to Treatment, or AE Causing Discontinuation of Treatment — 15.03; 14.93 events per…
Phase 4 N=30 Valganciclovir to Reduce T Cell Activation in HIV Infection
HIV Infections · Cytomegalovirus Infections
Primary: Change in %CD38+ Human Leukocyte Antigen-D-related (HLA-DR)+ CD8+ T Cells From Baseline to Week 8. — 1.3; -4.0 percentage of activated T cells
N/A N=362 A Study in Adolescent Females to Explore Cytomegalovirus Infection
Infections, Cytomegalovirus
Primary: Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum. — 5; 2 Participants
Phase 2 N=120 A Study of the Use of Oral Posaconazole (POS) in the Treatment of Asymptomatic Chronic Chagas Disease (P05267)
Chagas Disease
Primary: Percentage of Participants With a Successful Response as Measured by Qualitative Polymerase Chain Reaction — 15.6; 10.0; 82.1; 86.7 Percentage of participants
N/A N=500 Antenatal Chlamydia Trachomatis and Neisseria Gonorrhoeae Testing to Prevent Adverse Neonatal Consequences
Chlamydia Trachomatis Infection · Neonatal Infection · Preterm Birth
Primary: Number of Women Diagnosed With C. Trachomatis and N. Gonorrhoeae Infection at Post-delivery — 2; 23 Participants
N/A N=442 Cerebrotendinous Xanthomatosis (CTX) Prevalence Study
Cerebrotendinous Xanthomatosis (CTX)
Primary: Number of Participants Who Had Positive Genetic Test Results — 4 Participants
Phase 4 N=41 Loiasis Cross-reactive Antigenemia and Treatment-related Adverse Events
Loiasis
Primary: Cross-reactive Antigenemia — 12 Participants
Phase 3 N=209 Studies of the Ocular Complications of AIDS (SOCA)--Monoclonal Antibody CMV Retinitis Trial (MACRT)
HIV Infections · Cytomegalovirus Retinitis
Primary: Mortality Rate — 0.68; 0.31 deaths per person-year
Phase 2 N=370 S. Japonicum and Pregnancy Outcomes
Schistosomiasis
Primary: Mean Newborn Birth Weight — 2.85; 2.85 kilograms — p=0.988
N/A N=534 Organization of Teratology Information Services (OTIS) Autoimmune Diseases in Pregnancy Project
Pregnancy
Primary: Percentage of Infants With Major Birth Defects in Pregnancies Ending With Live-born Infants — 9.4; 3.5 percentage of participants
Phase 3 N=234 Studies of the Ocular Complications of AIDS (SOCA)--Foscarnet-Ganciclovir CMV Retinitis Trial (FGCRT)
HIV Infections · Cytomegalovirus Retinitis
Primary: Mortality — 107; 127 participants