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Human plague remains a public health concern in Tanzania despite its quiescence in most foci for years, considering the recurrence nature of the disease. Despite the long-standing history of this problem, there have not been recent reviews of the current knowledge on plague in Tanzania. This work aimed at providing a current overview of plague in Tanzania in terms of its introduction, potential reservoirs, possible causes of plague persistence and repeated outbreaks in the country. Plague is believed to have been introduced to Tanzania from the Middle East through Uganda with the first authentication in 1886. Xenopsylla brasiliensis, X. cheopis, Dinopsyllus lypusus, and Pulex irritans are among potential vectors while Lophuromys spp, Praomys delectorum, Graphiurus murinus, Lemniscomys striatus, Mastomys natalensis, and Rattus rattus may be the potential reservoirs. Plague persistence and repeated outbreaks in Tanzania are likely to be attributable to a complexity of factors including cultural, socio-economical, environmental and biological. Minimizing or preventing people's proximity to rodents is probably the most effective means of preventing plague outbreaks in humans in the future. In conclusion, much has been done on plague diagnosis in Tanzania. However, in order to achieve new insights into the features of plague epidemiology in the country, and to reorganize an effective control strategy, we recommend broader studies that will include the ecology of the pathogen, vectors and potential hosts, identifying the reservoirs, dynamics of infection and landscape ecology. [ABSTRACT FROM AUTHOR]

Background: Klebsiella pneumoniae strains expressing ESBLs are a predominant cause of hospital acquired infections. Here we describe the molecular epidemiology of these isolates in a tertiary hospital in Tanzania, as potential pathogens for neonatal infections. Methods: Between April 2009 and March 2010 all Klebsiella pneumoniae isolates with phenotypic expression Extended Spectrum Beta Lactamase (ESBL) were collected and characterized. Identification was done using in house biochemical tests in case of ambiguous results confirmation was done using API 20E. Susceptibility testing was determined using the disc diffusion method followed by specific PCR and sequencing to determine ESBL genes. Phylogenetic analysis, Pulse field gel electrophoresis (PFGE) and Multi-Locus sequence typing (MLST) to PFGE clusters representative isolates were performed to determine clones of the isolates. Conjugation and hybridization were performed to determine the location of blaCTX-M-15 gene. Results: A total of 92 non- repetitive ESBL producing K. pneumoniae representing 50.3% of Klebsiella pneumoniae isolates were characterized. These isolates were from blood 61 (66%), wound swab 13 (14%), urine 12 (13%) and pus 6 (7%) were analyzed. Most blood culture strains originated from neonatal unit 39/61(64%) and 22 (36%) of the blood culture isolates were from neonatal ICU. All isolates were resistant to gentamicin and 54% were resistant to ciprofloxacin. Using a similarity index of 80%, the isolates were assigned to thirteen clusters based on PFGE patterns and contained sub-clusters with identical strains indicating clonal outbreaks. Cluster X5, X7 and X8, and X9 were grouped into ST48, ST14 and ST348 respectively. Based on gyrA PCR- RFLP phylogenetic analysis all isolates were grouped as KpI. The predominant ESBL allele detected was blaCTX-M-15 which was found in 76% of isolates, followed by blaTEM-104 (19%), blaSHV-11 (3.2%) and blaTEM-176 (2%). The blaCTX-M-15 gene was located in multiple conjugative IncF plasmids ranging from 25 kb-485 kb in size. Conclusion: The high prevalence of blaCTX-M-15 observed among ESBL producing K. pneumoniae in Tanzania, is possibly due to the spread of a common IncFII 145 kb plasmid and of certain clones such as ST14 and ST48. Furthermore the 485 kb plasmid detected is the largest plasmid reported to carry blaCTX-M-15 todate. [ABSTRACT FROM AUTHOR]

Human immunodeficiency virus (HIV) DNA polymerase chain reaction (PCR) test using venous blood sample has been used for many years in low resource settings for early infant diagnosis of HIV infection in children less than 18 months. The aim of this study was to evaluate and compare the performance characteristics of Amplicor HIV-1 DNA assay version 1.5 following processing of venous blood and dried blood spot (DBS) samples by Roche manual DNA extraction and automated Roche MagNA Pure LC instrument (MP) for HIV-1 DNA PCR testing in Dar es Salaam, Tanzania, in order to scale up early infant diagnosis of HIV infection in routine practice. Venous blood samples from children under 18 months born to HIV-infected mothers between January and April 2008 were collected. Venous blood was used to prepare cell pellet and DBS samples. DNA extractions by manual procedure and MP were performed each on cell pellet, venous blood and DBS samples and tested by Amplicor HIV-1 DNA assay. Of 325 samples included, 60 (18.5%) were confirmed HIV-infected by manual extraction performed on cell pellets. Sensitivity of the assay following MP processing of venous blood was 95% (95% CI; 86.1-99.0%) and 98.3% (95% CI; 91.1 to 99.9%) for the manual extraction and processing by MP performed on DBS samples. Specificity of the assay with all DNA extraction methods was 99.6% (95% CI; 97.9 to 100%). Performance of the assay with Roche manual extraction and processing by MP on DBS samples compared well with Roche manual extraction performed on cell pellet samples. The choice of DNA extraction method needs to be individualized based on the level of laboratory facility, volume of testing and cost benefit analysis before it is adopted for use. [ABSTRACT FROM AUTHOR]

Background: Published data on the existence and magnitude of extended spectrum beta-lactamase (ESBL) production in urinary pathogens in local setting is limited. The aim of the present study was to determine the prevalence of antimicrobial resistance and ESBL production among Escherichia coli and Klebsiella spp from urine samples in a tertiary hospital. This was a cross sectional study conducted at Muhimbili National Hospital in Dar es Salaam, Tanzania. Findings: A total of 270 E.coli and Klebsiella spp urinary pathogens from children and adults isolated from January to March 2010 were included in the study. E. coli and Klebsiella spp isolates were tested for antimicrobial susceptibility by the Clinical and Laboratory Standard Institute's disc diffusion method. These isolates were further screened for ESBL phenotype using cefotaxime and ceftazidime discs. Isolates with reduced sensitivity were confirmed using ESBL E-test strips. Of 270 isolates, 138 (51.1%) were E. coli and 132 (48.9%) were Klebsiella spp. ESBL was detected in 122 (45.2%) of all the isolates. ESBL- producing E. coli strains were significantly more resistance to cotrimoxazole (90.7%), ciprofloxacin (46.3%) and nalidixic acid (61.6%) than strains that did not produce ESBL (p < 0.05). Similarly, ESBL- producing Klebsiella spp strains were significantly more resistance to cotrimoxazole (92.6%), ciprofloxacin (25.0%), nalidixic acid (66.2%), and gentamicin (38.2%) than strains that did not produce ESBL (P < 0.05). Multi-drug resistance was found to be significantly (P < 0.05) more in ESBL producing isolates (90.5%) than non ESBL producers (68.9%). The occurrence of ESBL was significantly higher among isolates from inpatients than outpatients [95 (50.5%) vs. 27(32.9%)] (p = 0.008). The occurrence of ESBL was significantly higher among isolates from children than in adults [84 (54.9%) vs. 38(32.5%)] (p < 0.001). Conclusions: High prevalence of ESBL-producing E. coli and Klebsiella spp strains was found among inpatients and children. Most of the ESBL- producing isolates were multi-drug resistant making available therapeutic choices limited. We recommend continued antibiotic surveillance as well comprehensive multi-center studies to address the emerging problem of ESBL-associated infections in order to preserve the continued usefulness of most antimicrobial drugs. Further more conducting molecular studies will help to evaluate the various ESBL types. [ABSTRACT FROM AUTHOR]

The aim of this study was to determine the prevalence of HIV-1 infection, the clinical spectrum of HIV-1-associated conditions and HIV-1-associated mortality among children hospitalized in the medical paediatric wards at Muhimbili Medical Centre (MMC), Dar es Salaam, Tanzania. All children admitted to the medical paediatric wards of MMC between August 1995 and January 1996 were eligible for the study. Testing for HIV antibodies was done using 2 consecutive enzyme linked immunosorbent assays (ELISAs). ELISA-reactive samples from children aged 18 months and below were further tested by a recently developed heat-denatured p24 antigen assay. The prevalence of HIV-1 infection among the 2015 children studied was 19.2%. When present for 14 days or more, fever, cough, diarrhoea, ear discharge, oral ulcers and skin rash were all significantly more common in HIV-1-infected than in HIV-uninfected children (p < 0.001). In the multivariate analysis cough, ear discharge, oropharyngeal ulcers and skin rash were found to be the most important symptoms. Clinical signs found to be significantly associated with HIV-1 infection in the univariate analysis were wasting, stunting, hair changes, oral thrush, oropharyngeal ulcers, lymphadenopathy, lung consolidation and lung crepitations (p < 0.001). In the multivariate analysis, oral thrush, lung crepitations, cervical lymphadenopathy, wasting and inguinal lymphadenopathy were found to be the most important signs. The 3 most common diagnoses in HIV-1-infected children were acute respiratory infection (ARI) (39.4%), malnutrition (38.1%) and tuberculosis (19.3%), while in HIV-uninfected children they were malaria (47.0%), ARI (25.0%) and malnutrition (16.1%). The mortality rate was 21.4% in HIV-1-infected children and 8.4% in HIV-uninfected children (p < 0.001). In conclusion, the prevalence of HIV-1 infection among hospitalized children at the main hospital in Dar es Salaam was high and associated with high mortality. Many symptoms and signs are indicative of HIV-1 infection, but appropriate laboratory testing is required for diagnosis. [ABSTRACT FROM AUTHOR]

An abstract of the article "Immune Responses after Two Immunizations with rgp140/GLA Following Priming with HIV-DNA and HIV-MVA in Healthy Tanzanian Volunteers" by Agricola Joachim and colleagues is presented.

This study aimed to determine the prevalence of Staphylococcus aureus and methicillin-resistant S. aureus (MRSA) carriage, risk factors of colonization and antimicrobial susceptibility patterns of S. aureus strains. The study was conducted at the Muhimbili National Hospital in Dar es Salaam, Tanzania. Nasal swabs were obtained from children and S. aureus was isolated and identified using conventional culture methods. MRSA was screened and confirmed using the cefoxitin disk and multiplex real-time polymerase chain reaction, respectively. Antibiotic susceptibility was performed using the Kirby-Bauer disk diffusion method. MRSA isolates were further characterized by pulsed field gel electrophoresis (PFGE) profiling. Of 285 children included in the study, S. aureus was detected in 114 (40%). Of the 114 isolates, 12 (10.5%) were MRSA. PFGE results showed that these MRSA isolates are epidemiologically unrelated. Resistance of all S. aureus to trimethoprim-sulfamethoxazole, tetracycline, gentamicin, and ciprofloxacin was 65.8%, 23.7%, 27.2%, and 4.4%, respectively. No resistance to vancomycin was found. The prevalence of inducible clindamycin resistance, constitutive clindamycin resistance, MS phenotype (resistance to erythromycin alone), and multidrug resistance was 16.7%, 1.8%, 14.0%, and 16.8%, respectively. None of the risk factors examined was found to be significant. This is the first report of S. aureus and nasal carriage of MRSA and a high rate of S. aureus carriage was found in Tanzanian under-5 children. The study findings support the need for proper health education and effective infection control measures for healthcare workers. [ABSTRACT FROM AUTHOR]

Abstract: Enterobacter hormaechei and Cronobacter sakazakii are amongst the most important causes of outbreaks of neonatal sepsis associated with powdered milk. In this study, we report for the first time an outbreak of a novel Enterobacter sp. harbouring bla CTX-M-15 in a neonatal unit in Tanzania. Seventeen Gram-negative enteric isolates from neonatal blood cultures were studied. Antibiotic susceptibility was assessed by disc diffusion testing, and the presence of the bla CTX-M-15 gene was established by polymerase chain reaction (PCR) and sequencing. Isolates were typed by pulsed-field gel electrophoresis (PFGE). Identification by biochemical profiling was followed by nucleotide sequencing of 16S ribosomal DNA (rDNA), rpoB and hsp60 alleles. Environmental sampling was done and control measures were established. Isolates were initially misidentified based on their fermentation characteristics and agglutination as Salmonella enterica serotype Paratyphi. All isolates were resistant to multiple antibiotics, except for ciprofloxacin and carbapenems, and were found to harbour bla CTX-M-15 on a 291-kb narrow-range plasmid. PFGE analysis indicated the clonal outbreak of a single strain, infecting 17 neonates with a case fatality rate of 35%. The same strain was isolated from a milk bucket. Phylogenetic analysis using 16S rDNA, rpoB and hsp60 sequences permitted no definitive identification, clustering the strains in the Enterobacter cloacae complex with similarities of 92–98.8%. The data describe an outbreak of a novel bla CTX-M-15-positive, multiresistant Enterobacter strain in an African neonatal unit that can easily be misidentified taxonomically. These data highlight the need for constant surveillance of bacteria harbouring extended-spectrum β-lactamases as well as improvements in hygiene measures in developing countries. [Copyright &y& Elsevier]

Objectives: The objectives are to determine the prevalence of urinary tract infection (UTI) and associated factors among patients diagnosed with benign prostatic hyperplasia and prostate cancer., Design: Hospital-based cross-sectional study., Settings: Urology clinic and urology ward at Muhimbili National Hospital, which is the main tertiary hospital in Tanzania's largest city., Participants: Patients with benign prostate hyperplasia and prostate cancer presenting with genitourinary symptoms., Main Outcome Measure: The primary outcome was the occurrence of UTI and factors associated with UTI in patients with benign prostatic hyperplasia and prostate cancer., Results: 402 participants were enrolled, with a median age of 68 years and IQR of 61-75 years. The proportion of UTI was 46.5% (95% CI 41.56% to 51.53%). UTI was more prevalent among inpatients, patients with indwelling urinary catheters, patients with prostate size>80 cm 3 and those with residual urine volume of >100 mL. In multivariate analysis, age>60 years (adjusted OR (aOR)=2.0, 95% CI 1.13 to 3.55, p=0.018), post-void residual urine volume>100 mL (aOR 1.32, 95% CI 0.67 to 2.59 p=0.001), patient with incomplete bladder emptying (aOR=2.57, 95% CI 1.44 to 4.59, p=0.001) and prolonged catheter duration (aOR=1.24, 95% CI 1.11 to 1.38, p=0.005) were significantly associated with UTI., Conclusion: Almost half of the patients with an enlarged prostate and genitourinary symptoms had a laboratory-confirmed UTI. The risk of UTI increases with age, incomplete bladder emptying and increased duration of catheterisation. A 1-day increase in the duration of catheterisation increased the risk of UTI by 24%., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: A cohort of female sex workers (FSWs) was established to determine HIV prevalence and incidence, and associated factors in preparation for a phase IIb HIV vaccine and pre-exposure prophylaxis trial (PrEPVacc)., Setting: A cohort of FSWs in Dar es Salaam, Tanzania., Methods: FSWs aged 18-45 years were recruited using a respondent-driven sampling method. Social demographic data, HIV risk behavioral assessments, and blood samples for testing of HIV, syphilis, hepatitis B (HBV), and hepatitis C (HCV) infections were collected at baseline and then at 3, 6, 9, and 12 months. Poisson regressions were used to estimate the prevalence ratios for factors associated with HIV prevalence and to estimate the 12-month HIV incidence rate., Results: Between October and December 2018, a total of 773 FSWs were screened for eligibility and 700 were enrolled. The baseline prevalence of HIV, syphilis, HBV, and HCV was 7.6%, 1.2%, 1.7%, and 1.0%, respectively. HIV prevalence was associated with older age, using illicit drugs, and being infected with syphilis, HBV, or HCV. Attendance at 12 months was 80% (562/700). Twenty-one FSWs seroconverted during follow-up, giving a 12-month HIV incidence rate of 3.45 per 100 person-years at risk (95% CI; 2.25-5.28/100 person-years at risk). The HIV incidence rate was higher among FSWs aged 18-24 years, FSWs who used drugs, and those diagnosed with syphilis, HBV, or HCV., Conclusion: The high HIV incidence rate and retention rate among FSWs enrolled into the cohort demonstrate that this population is suitable for participation in HIV prevention trials., Competing Interests: The authors have no funding or conflicts of interest to disclose., (Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc.)

Background: We evaluated the safety and immunogenicity of (i) an intradermal HIV-DNA regimen given with/without intradermal electroporation (EP) as prime and (ii) the impact of boosting with modified vaccinia virus Ankara (HIV-MVA) administered with or without subtype C CN54rgp140 envelope protein adjuvanted with Glucopyranosyl Lipid A (GLA-AF) in volunteers from Tanzania and Mozambique., Methods: Healthy HIV-uninfected adults (N = 191) were randomized twice; first to one of three HIV-DNA intradermal priming regimens by needle-free ZetaJet device at weeks 0, 4 and 12 (Group I: 2x0.1mL [3mg/mL], Group II: 2x0.1mL [3mg/mL] plus EP, Group III: 1x0.1mL [6mg/mL] plus EP). Second the same volunteers received 108 pfu HIV-MVA twice, alone or combined with CN54rgp140/GLA-AF, intramuscularly by syringe, 16 weeks apart. Additionally, 20 volunteers received saline placebo., Results: Vaccinations and electroporation did not raise safety concerns. After the last vaccination, the overall IFN-γ ELISpot response rate to either Gag or Env was 97%. Intradermal electroporation significantly increased ELISpot response rates to HIV-DNA-specific Gag (66% group I vs. 86% group II, p = 0.026), but not to the HIV-MVA vaccine-specific Gag or Env peptide pools nor the magnitude of responses. Co-administration of rgp140/GLA-AF with HIV-MVA did not impact the frequency of binding antibody responses against subtype B gp160, C gp140 or E gp120 antigens (95%, 99%, 79%, respectively), but significantly enhanced the magnitude against subtype B gp160 (2700 versus 300, p<0.001) and subtype C gp140 (24300 versus 2700, p<0.001) Env protein. At relatively low titers, neutralizing antibody responses using the TZM-bl assay were more frequent in vaccinees given adjuvanted protein boost., Conclusion: Intradermal electroporation increased DNA-induced Gag response rates but did not show an impact on Env-specific responses nor on the magnitude of responses. Co-administration of HIV-MVA with rgp140/GLA-AF significantly enhanced antibody responses., Competing Interests: The authors have declared that no competing interests exist.

Tanzania requires more health professionals equipped to tackle its serious health challenges. When it became an independent university in 2007, Muhimbili University of Health and Allied Sciences (MUHAS) decided to transform its educational offerings to ensure its students practice competently and contribute to improving population health. In 2008, in collaboration with the University of California San Francisco (UCSF), all MUHAS's schools (dentistry, medicine, nursing, pharmacy, and public health and social sciences) and institutes (traditional medicine and allied health sciences) began a university-wide process to revise curricula. Adopting university-wide committee structures, procedures, and a common schedule, MUHAS faculty set out to: (i) identify specific competencies for students to achieve by graduation (in eight domains, six that are inter-professional, hence consistent across schools); (ii) engage stakeholders to understand adequacies and inadequacies of current curricula; and (iii) restructure and revise curricula introducing competencies. The Tanzania Commission for Universities accredited the curricula in September 2011, and faculty started implementation with first-year students in October 2011. We learned that curricular revision of this magnitude requires: a compelling directive for change, designated leadership, resource mobilization inclusion of all stakeholders, clear guiding principles, an iterative plan linking flexible timetables to phases for curriculum development, engagement in skills training for the cultivation of future leaders, and extensive communication.

In 2005, Muhimbili University of Health and Allied Sciences (MUHAS) in Tanzania and the University of California San Francisco (UCSF) in the United States joined to form a partnership across all the schools in our institutions. Although our goal is to address the health workforce crisis in Tanzania, we have gained much as institutions. We review the work undertaken and point out how this education partnership differs from many research collaborations. Important characteristics include: (i) activities grew out of MUHAS's institutional needs, but also benefit UCSF; (ii) working across professions changed the discourse from 'medical education' to 'health professions education'; (iii) challenged by gaps in our respective health-care systems, both institutions chose a new focus, interprofessional team work; (iv) despite being so differently resourced, MUHAS and UCSF seek strategies to address growing class sizes; and (v) we involved a wider range of people - faculty, administrators, students, and residents - at both institutions than is usually the case with research. This partnership has convinced us to exhort other academic leaders in the health arena to seek opportunities together to enlighten and enliven our educational enterprises.

Objective: The main aim of this study was to reduce breast-milk transmission of HIV-1 by treating HIV-1-infected women with highly active antiretroviral therapy (HAART) during breastfeeding., Methods: Mitra Plus was an open-label, nonrandomized, prospective cohort study. HIV-1-infected pregnant women in Dar es Salaam were treated with zidovudine (ZDV) + lamivudine (3TC) + nevirapine (NVP). NVP was later replaced by nelfinavir for mothers with CD4 cell counts >200 cells per microliter or with adverse reaction to NVP. HAART was initiated at 34 weeks of gestation. For women with symptomatic HIV infection or CD4 cell counts below 200 cells per microliter, HAART was started earlier if possible. Treatment of the mothers was stopped at 6 months except for those mothers who needed HAART for their own health. The infants received ZDV + 3TC for 1 week after birth. Mothers were advised to exclusively breastfeed and to wean abruptly between 5 and 6 months. Transmission of HIV-1 was analyzed using the Kaplan-Meier survival technique. Cox regression was used for comparison with the breastfeeding population of the Petra trial arm A., Results: There were 441 infants included in the analysis of HIV-1 transmission. The cumulative transmission of HIV-1 was 4.1 % [95% confidence interval (CI): 2.2 to 6.0] at 6 weeks, 5.0% (95% CI: 2.9 to 7.1) at 6 months, and 6.0% (95% CI: 3.7 to 8.3) at 18 months after delivery. The cumulative risk of HIV transmission between 6 weeks and 6 months was 1.0% and between 6 months and 18 months 1.1%. The cumulative HIV infection or death rate was 8.6% (95% CI: 6.0 to 11.2) at 6 months and 13.6% (95% CI: 10.3 to 16.9) at 18 months after delivery. Viral load at enrollment and duration of HAART before delivery were significantly associated with transmission but CD4 cell count at enrollment was not. The median time of breastfeeding was 24 weeks. The transmission in the Mitra Plus study was about half of the transmission in the breastfeeding population in the Petra trial arm A at 6 months after delivery (adjusted relative hazard = 0.49, P < 0.001). The combined outcome HIV infection or death was significantly lower in the Mitra Plus study than in the breastfeeding population in the Petra trial arm A at 18 months (adjusted relative hazard = 0.61, P = 0.007). NVP-related mucocutaneous rash was demonstrated in 6.5% of 429 NVP-exposed women. The incidence of NVP-related grade 3 or 4 hepatotoxicity was low (0.5%)., Conclusions: HAART given to HIV-infected mothers in late pregnancy and during breastfeeding resulted in a low postnatal HIV transmission similar to that previously demonstrated in the Mitra study in Dar es Salaam using infant prophylaxis with 3TC during breastfeeding. The extended maternal prophylaxis with HAART for prevention of mother-to-child transmission of HIV-1 for breastfeeding mothers who do not need HAART for their own health should be further evaluated and compared with the use of infant postnatal antiretroviral prophylaxis regarding safety and cost-effectiveness.

Objective: To investigate the possibility of reducing mother-to-child transmission (MTCT) of HIV-1 through breast-feeding by prophylactic antiretroviral (ARV) treatment of the infant during the breast-feeding period., Design: An open-label, nonrandomized, prospective cohort study in Tanzania (Mitra)., Methods: HIV-1-infected pregnant women were treated according to regimen A of the Petra trial with zidovudine (ZDV) and lamivudine (3TC) from week 36 to 1 week postpartum. Infants were treated with ZDV and 3TC from birth to 1 week of age (Petra arm A) and then with 3TC alone during breast-feeding (maximum of 6 months). Counseling emphasized exclusive breast-feeding. HIV transmission was analyzed using the Kaplan-Meier survival technique. Cox regression was used for comparison with the breast-feeding population in arm A of the Petra trial, taking CD4 cell count and other possible confounders into consideration., Results: There were 398 infants included in the transmission analysis in the Mitra study. The estimated cumulative proportion of HIV-1-infected infants was 3.8% (95% confidence interval [CI]: 2.0 to 5.6) at week 6 after delivery and 4.9% (95% CI: 2.7 to 7.1) at month 6. The median time of breast-feeding was 18 weeks. High viral load and a low CD4 T-cell count at enrollment were associated with transmission. The Kaplan-Meier estimated risk of HIV-1 infection at 6 months in infants who were HIV-negative at 6 weeks was 1.2% (95% CI: 0.0 to 2.4). The cumulative HIV-1 infection or death rate at 6 months was 8.5% (95% CI: 5.7 to 11.4). No serious adverse events related to the ARV treatment of infants occurred. The HIV-1 transmission rate during breast-feeding in the Mitra study up to 6 months after delivery was more than 50% lower than in the breast-feeding population of Petra arm A (relative hazard=2.61; P=0.001; adjusted values). The difference in transmission up to 6 months was significant also in the subpopulation of mothers with CD4 counts>or=200 cells/microL., Conclusions: The rates of MTCT of HIV-1 in the Mitra study at 6 weeks and 6 months after delivery are among the lowest reported in a breast-feeding population in sub-Saharan Africa. Prophylactic 3TC treatment of infants to prevent MTCT of HIV during breast-feeding was well tolerated by the infants and could be a useful strategy to prevent breast milk transmission of HIV when mothers do not need ARV treatment for their own health.