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Phase I/II Randomized Trial of Safety and Immunogenicity of LIPO-5 Alone, ALVAC-HIV (vCP1452) Alone, and ALVAC-HIV (vCP1452) Prime/LIPO-5 Boost in Healthy, HIV-1-Uninfected Adult Participants.
Clin. Vaccine Immunol.
PUBLISHED: 09-24-2014
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Finding an effective human immunodeficiency virus type 1 (HIV-1) vaccine remains a major global health priority. In a phase I/II, placebo-controlled trial, healthy, HIV-1-negative adults were randomized to receive one of 5 vaccine regimens: LIPO-5 (combination of 5 lipopeptides) alone (250 ?g), ALVAC-HIV (vCP1452) alone, or 3 groups of ALVAC-HIV (vCP1452) followed by ALVAC-HIV (vCP1452) plus LIPO-5 (250, 750, and 2,500 ?g). Only 73/174 participants (42%) received all four vaccinations due to a study halt related to myelitis. There were no significant differences in systemic reactions between groups or in local reactogenicity between groups receiving ALVAC-HIV (vCP1452). Significant differences in local reactogenicity occurred between groups receiving LIPO-5 (P ? 0.05). Gag and Env antibodies were undetectable by ELISA 2 weeks after the fourth vaccination for all but one recipient. Antibodies to Gag and Env were present in 32% and 24% of recipients of ALVAC-HIV (vCP1452) alone and in 47% and 35% of ALVAC-HIV (vCP1452)+LIPO recipients, respectively. Coadministration of LIPO-5 did not significantly increase the response rate compared to ALVAC-HIV (vCP1452) alone, nor was there a significant relationship between dose and antibody responses among ALVAC-HIV (vCP1452)+LIPO groups. Over 90% of study participants had no positive gamma interferon (IFN-?) enzyme-linked immunosorbent spot assay (ELISpot) responses to any peptide pool at any time point. The study was halted due to a case of myelitis possibly related to the LIPO-5 vaccine; this case of myelitis remains an isolated event. In general, there was no appreciable cell-mediated immunity detected in response to the vaccines used in this study, and antibody responses were limited. The clinical trial is registered on ClinicalTrials.gov with registry number NCT00076063.
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Neurocognitive impairment associated with predominantly early stage HIV infection in Abuja, Nigeria.
J. Neurovirol.
PUBLISHED: 01-05-2014
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Detailed neuropsychological testing was performed on 133 human immunodeficiency virus (HIV) seropositive (SP) and 77 HIV seronegative (SN) individuals, 86 % with early stage HIV infection in Nigeria, to determine the frequency of HIV-related neurocognitive impairment among the HIV-infected group. The tests were administered to assess the following seven ability domains: speed of information processing, attention/working memory, executive functioning, learning, memory, verbal fluency, and motor function motor. Demographically corrected individual test scores and scores for each domain or reflecting a global deficit (a global deficit score, or GDS) were compared for the SP and SN groups. SP participants were older, had fewer years of education, were more likely to be married, differed in ethnicity, and had higher depression scores than SN individuals. Within the seven ability domains, SP performed worse than SN with respect to speed of information processing, executive function, learning, memory, and verbal fluency and also on the global measure. SP were also more frequently impaired on tests of SIP, and there was a borderline increase in the frequency of global impairment. On the individual tests, SP performed worse than SN on four tests that assessed learning, verbal fluency, memory, and motor function (the Timed Gait). SP subjects, however, performed better than SN on the Finger-tapping test, also a motor task. Performance by SP subjects was not associated on the timed gait which showed a borderline statistically significant correlation with CD4 counts. However, there were significant correlations between viral load measurements and individual tests of speed of information processing, executive function, learning, and verbal fluency and with overall executive function and a borderline correlation with the GDS. Depression scores for SP were associated with impairment on only a single test of executive function. These results demonstrate the ability of these assessments to identify areas of impairment that may be specifically linked to a history of HIV infection among individuals in Nigeria. Confirmation of these findings awaits analyses using data from a larger number of control subjects.
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Tenofovir-based regimens associated with less drug resistance in HIV-1-infected Nigerians failing first-line antiretroviral therapy.
AIDS
PUBLISHED: 08-22-2013
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In resource-limited settings, HIV-1 drug resistance testing to guide antiretroviral therapy (ART) selection is unavailable. We retrospectively conducted genotypic analysis on archived samples from Nigerian patients who received targeted viral load testing to confirm treatment failure and report their drug resistance mutation patterns.
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Comparison of HIV oral fluid and plasma antibody results during early infection in a longitudinal Nigerian cohort.
J. Clin. Virol.
PUBLISHED: 06-14-2013
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Oral fluid (OF) testing is a less-invasive alternative to blood-based testing for HIV. The performance of HIV OF tests has not been extensively evaluated in serially collected paired specimens from seroconverters.
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Elevated hypermutation levels in HIV-1 natural viral suppressors.
Virology
PUBLISHED: 04-05-2013
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Mutations in the HIV-1 proviral genomes delay the progression of the disease. We compared the mutation status in full-length proviral genomes of 23 HIV-infected patients with undetectable viral loads in the absence of therapy named natural viral suppressors (NVS) or Elite Controllers with 23 HIV-infected controls (10 patients on HAART treatment and 13 untreated patients). Provirus DNA was extracted from PBMC for amplification and sequencing to determine the mutation status. Nine (39 %) of the 23 NVS patients had defective proviral genomes, compared to 4 of the treated controls (40%, p = 0.96) and only one of the untreated controls (8%, p = 0.059). Most of the defective genomes resulted from Gto-A hypermutation. Among patients with hypermutation, the rate ratio for mutation was significantly higher for the NVS compared to treated controls (p = 0.043). Our data suggests that inactivation of the virus through the APOBEC3G system may contribute to the NVS phenotype.
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Mycobacterial Etiology of Pulmonary Tuberculosis and Association with HIV Infection and Multidrug Resistance in Northern Nigeria.
Tuberc Res Treat
PUBLISHED: 03-22-2013
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Objective. Data on pulmonary tuberculosis (TB) caused by Mycobacterium tuberculosis (MTB) complex in Nigeria are limited. We investigated species of MTB complex in TB cases from northern Nigeria. Methods. New TB suspects were enrolled, screened for HIV and their sputum samples were cultured after routine microscopy. Genotypes MTBC and MTBDRplus were used to characterize the MTB complex species and their resistance to isoniazid and rifampicin. Results. Of the 1,603 patients enrolled, 375 (23%) had MTB complex infection: 354 (94.4%) had Mycobacterium tuberculosis; 20 (5.3%) had Mycobacterium africanum; and one had Mycobacterium bovis (0.3%). Cases were more likely to be male (AOR = 1.87, 95% CI?:?1.42-2.46; P ? 0.001), young (AOR = 2.03, 95% CI?:?1.56-2.65; P ? 0.001) and have HIV (AOR = 1.43, 95% CI?:?1.06-1.92; P = 0.032). In 23 patients (6.1%), the mycobacterium was resistant to at least one drug, and these cases were more likely to have HIV and prior TB treatment (AOR = 3.62, 95% CI?:?1.51-8.84; P = 0.004; AOR?:?4.43; 95% CI?:?1.71-11.45 P = 0.002 resp.), compared to cases without any resistance. Conclusion. Mycobacterium tuberculosis remained the predominant specie in TB in this setting followed by Mycobacterium africanum while Mycobacterium bovis was rare. The association of TB drug resistance with HIV has implications for TB treatment.
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Immuno-virologic outcomes and immuno-virologic discordance among adults alive and on anti-retroviral therapy at 12 months in Nigeria.
BMC Infect. Dis.
PUBLISHED: 02-27-2013
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Predictors of immuno-virologic outcomes and discordance and their associations with clinical, demographic, socio-economic and behavioral risk factors are not well described in Nigeria since HIV viral load testing is not routinely offered in public HIV treatment programs.
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Immunologic outcomes of antiretroviral therapy among HIV-infected Nigerian children and its association with early infant feeding and nutritional status at treatment initiation.
Pediatr. Infect. Dis. J.
PUBLISHED: 02-16-2013
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To evaluate immunologic response to antiretroviral treatment (ART) among HIV-infected Nigerian children (<36 months old) and to assess its association with early infant feeding pattern and nutritional status at treatment initiation.
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Cervical cancer risk factors among HIV-infected Nigerian women.
BMC Public Health
PUBLISHED: 01-12-2013
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Cervical cancer is the third most common cancer among women worldwide, and in Nigeria it is the second most common female cancer. Cervical cancer is an AIDS-defining cancer; however, HIV only marginally increases the risk of cervical pre-cancer and cancer. In this study, we examine the risk factors for cervical pre-cancer and cancer among HIV-positive women screened for cervical cancer at two medical institutions in Abuja, Nigeria.
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Prevalence of non-tuberculous mycobacterial infections among tuberculosis suspects in Nigeria.
PLoS ONE
PUBLISHED: 01-01-2013
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Nigeria is ranked in the top five countries for tuberculosis deaths worldwide. This study investigated the mycobacterial agents associated with presumptive clinical pulmonary tuberculosis (TB) in Nigeria and evaluated the pattern and frequency of mycobacterial infections over twelve calendar months period.
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Timing of plasmid cytokine (IL-2/Ig) administration affects HIV-1 vaccine immunogenicity in HIV-seronegative subjects.
J. Infect. Dis.
PUBLISHED: 09-21-2011
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To investigate the potential immunostimulatory effect of interleukin (IL) 2 as a human immunodeficiency virus type 1 (HIV-1) vaccine adjuvant, we conducted a study of a plasmid coding for a fusion protein of IL-2 and immunoglobulin (IL-2/Ig).
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Recurrent signature patterns in HIV-1 B clade envelope glycoproteins associated with either early or chronic infections.
PLoS Pathog.
PUBLISHED: 06-26-2011
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Here we have identified HIV-1 B clade Envelope (Env) amino acid signatures from early in infection that may be favored at transmission, as well as patterns of recurrent mutation in chronic infection that may reflect common pathways of immune evasion. To accomplish this, we compared thousands of sequences derived by single genome amplification from several hundred individuals that were sampled either early in infection or were chronically infected. Samples were divided at the outset into hypothesis-forming and validation sets, and we used phylogenetically corrected statistical strategies to identify signatures, systematically scanning all of Env. Signatures included single amino acids, glycosylation motifs, and multi-site patterns based on functional or structural groupings of amino acids. We identified signatures near the CCR5 co-receptor-binding region, near the CD4 binding site, and in the signal peptide and cytoplasmic domain, which may influence Env expression and processing. Two signatures patterns associated with transmission were particularly interesting. The first was the most statistically robust signature, located in position 12 in the signal peptide. The second was the loss of an N-linked glycosylation site at positions 413-415; the presence of this site has been recently found to be associated with escape from potent and broad neutralizing antibodies, consistent with enabling a common pathway for immune escape during chronic infection. Its recurrent loss in early infection suggests it may impact fitness at the time of transmission or during early viral expansion. The signature patterns we identified implicate Env expression levels in selection at viral transmission or in early expansion, and suggest that immune evasion patterns that recur in many individuals during chronic infection when antibodies are present can be selected against when the infection is being established prior to the adaptive immune response.
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A phase IIA randomized clinical trial of a multiclade HIV-1 DNA prime followed by a multiclade rAd5 HIV-1 vaccine boost in healthy adults (HVTN204).
PLoS ONE
PUBLISHED: 03-01-2011
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The safety and immunogenicity of a vaccine regimen consisting of a 6-plasmid HIV-1 DNA prime (envA, envB, envC, gagB, polB, nefB) boosted by a recombinant adenovirus serotype-5 (rAd5) HIV-1 with matching inserts was evaluated in HIV-seronegative participants from South Africa, United States, Latin America and the Caribbean.
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Phase 1 safety and immunogenicity testing of DNA and recombinant modified vaccinia Ankara vaccines expressing HIV-1 virus-like particles.
J. Infect. Dis.
PUBLISHED: 01-31-2011
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Recombinant DNA and modified vaccinia virus Ankara (rMVA) vaccines represent a promising approach to an HIV/AIDS vaccine. This Phase 1 clinical trial compared the safety and immunogenicity of a rMVA vaccine administered with and without DNA vaccine priming
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Significantly longer envelope V2 loops are characteristic of heterosexually transmitted subtype B HIV-1 in Trinidad.
PLoS ONE
PUBLISHED: 01-19-2011
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In Trinidad and the wider Caribbean, subtype B Human Immunodeficiency Virus-type 1 (HIV-1B) overwhelmingly accounts for HIV infection among heterosexuals; this contrasts with the association of HIV-1B with homosexual transmission and injecting drug use globally. The HIV envelope contains genetic determinants of cell tropism and evasion from immune attack. In this study we investigate the genetic properties of the env V1-C4 of HIV-1B soon after transmission to Trinidadian heterosexuals. This will reveal distinctive genetic features of the strains that cause the HIV-1B epidemic in Trinidad and generate insights to better understand their properties.
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Experiences in establishing a PEPFAR-supported laboratory quality system in Nigeria.
Am. J. Clin. Pathol.
PUBLISHED: 09-22-2010
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The need to accurately diagnose HIV-infected persons and monitor their immune status and sequelae from increased access to antiretroviral therapy dictated the establishment of a quality assurance (QA) system supported by dedicated personnel, financial resources, and a close monitoring system. Assessment of laboratories and personnel in Nigeria revealed the need for improved laboratory infrastructure and training, including on-site didactic and wet workshops and the institution of a tiered QA unit of laboratory regional officers, focal persons, and site monitors who provided guidance and continuous monitoring. Quarterly assessments and generated reports guided corrective actions. A sustainable quality laboratory system was developed for the first time in Nigeria with funding from the US Presidents Emergency Plan for AIDS Relief. With expansion from 7 to 34 comprehensive treatment sites, a tiered laboratory organizational structure with regional and site-based Nigerian quality control officers was developed. Measured improvements included reduction in deficiencies from 13% to 2%.
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Screening for hazardous alcohol use and depressive symptomatology among HIV-infected patients in Nigeria: prevalence, predictors, and association with adherence.
J Int Assoc Physicians AIDS Care (Chic)
PUBLISHED: 08-28-2010
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Scores from the Alcohol Use Disorders Identification Test (AUDIT) and the Center for Epidemiological Studies Depression Scale (CES-D) administered to both antiretroviral therapy (ART)-experienced and -naive adults in HIV care in Nigeria were evaluated for association with participant characteristics and ART adherence measured by pharmacy records. Participants included 222 ART-experienced and 177 ART-naive adults, of whom 47 (12%) had AUDIT >/=8, 29 (7%) an AUDIT >/=10, 52 (13%) a CES-D >/=16, and 25 (6%) a CES-D >/=21. An elevated AUDIT score was more frequent among ART-naive and men, while disclosure of HIV status to others was associated with lower scores. An elevated CES-D score was more frequent among ART-naive and those with lower educational level, while disclosure of HIV status and choosing to be interviewed in English rather than Hausa was associated with lower scores. An elevated CES-D score was associated with poor adherence.
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HIV infection awareness and willingness to participate in future HIV vaccine trials across different risk groups in Abuja, Nigeria.
AIDS Care
PUBLISHED: 07-28-2010
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The purpose of this survey is to generate baseline data on the level of HIV infection awareness and willingness to participate (WTP) in hypothetical vaccine trials, ahead of any trial conduct in Nigeria. In a cross-sectional survey, 500 respondents were interviewed, including sex workers, male motorcycle taxi drivers, students, and the general public. About 153 (30.6%) of the respondents did not believe that correct and consistent use of condom can protect people from getting HIV, while about 66 (13.2%) respondents believed it is possible to get HIV by sharing meal with an infected person. Population groups considered at high risk for HIV were less aware of the disease, however, they were more willing to participate in HIV vaccine trials compared those at low risk of the disease. A total of 55% expressed WTP in a hypothetical vaccine trial after they were informed about it. Age, population group, and ethnicity were significantly associated with WTP.
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Patient retention and adherence to antiretrovirals in a large antiretroviral therapy program in Nigeria: a longitudinal analysis for risk factors.
PLoS ONE
PUBLISHED: 04-02-2010
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Substantial resources and patient commitment are required to successfully scale-up antiretroviral therapy (ART) and provide appropriate HIV management in resource-limited settings. We used pharmacy refill records to evaluate risk factors for loss to follow-up (LTFU) and non-adherence to ART in a large treatment cohort in Nigeria.
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A novel HIV T helper epitope-based vaccine elicits cytokine-secreting HIV-specific CD4+ T cells in a Phase I clinical trial in HIV-uninfected adults.
Vaccine
PUBLISHED: 03-26-2009
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A Phase I human vaccine trial of a novel polypeptide vaccine of HIV T helper epitopes (EP-1043) and a DNA vaccine of HIV CTL epitopes was conducted in 84 healthy adult volunteers. The vaccine immunogenicity was assessed by an intracellular cytokine staining assay for IL-2, IL-4, TNF-alpha and IFN-gamma. Sixty eight percent (32/47) of subjects had a positive CD4+ T response after receiving two vaccinations of the polypeptide vaccine. The responding CD4+ T cells made various combinations of IL-2, IL-4, IFN-gamma, and TNF-alpha. The study demonstrated that the EP-1043 vaccine is safe, well-tolerated, and immunogenic.
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HIV-1 epidemic in the Caribbean is dominated by subtype B.
PLoS ONE
PUBLISHED: 02-04-2009
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The molecular epidemiology of HIV-1 in the Caribbean has been described using partial genome sequencing; subtype B is the most common subtype in multiple countries. To expand our knowledge of this, nearly full genome amplification, sequencing and analysis was conducted.
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In vivo gp41 antibodies targeting the 2F5 monoclonal antibody epitope mediate human immunodeficiency virus type 1 neutralization breadth.
J. Virol.
PUBLISHED: 02-04-2009
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The broadly neutralizing human monoclonal antibodies (MAbs) 2F5 and 4E10, both targeting the highly conserved human immunodeficiency virus type 1 (HIV-1) envelope membrane proximal external region (MPER), are among the MAbs with the broadest heterologous neutralizing activity and are of considerable interest for HIV-1 vaccine development. We have identified serum antibodies from an HIV-infected subject that both were broadly neutralizing and specifically targeted MPER epitopes that overlap the 2F5 epitope. These MPER-specific antibodies were made 15 to 20 months following transmission and concomitantly with the development of autoantibodies. Our findings suggest that multiple events (i.e., genetic predisposition and HIV-1 immune dysregulation) may be required for induction of broadly reactive gp41 MPER antibodies in natural infection.
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Timing and determinants of mother-to-child transmission of HIV in Nigeria.
Int J Gynaecol Obstet
PUBLISHED: 01-21-2009
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To characterize the timing and determinants of mother-to-child transmission (MTCT) of HIV among mothers receiving single-dose nevirapine to prevent MTCT in Nigeria.
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HIV counseling and testing and access-to-care needs of populations most-at-risk for HIV in Nigeria.
AIDS Care
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Mobile HIV counseling and testing (mHCT) is an effective tool to access hard-to-reach most-at-risk populations (MARPs), but identifying which populations are not accessing services is often a challenge. We compared correlates of human immunodeficiency virus (HIV) infection and awareness of HIV care services among populations tested through mHCT and at testing facilities in Nigeria. Participants in a cross-sectional study completed a questionnaire and HCT between May 2005 and March 2010. Of 27,586 total participants, 26.7% had been previously tested for HIV; among mHCT clients, 14.7% had previously been tested. HIV prevalence ranged from 6.6% among those tested through a facility to 50.4% among brothel-based sex workers tested by mHCT. Among mHCT participants aged 18-24, women were nine times more likely to be infected than men. Women aged 18-24 were also less likely than their male counterparts to know that there were medicines available to treat HIV (63.2 vs. 68.1%; p=0.03). After controlling for gender, age, and other risk factors, those with current genital ulcer disease were more likely to be HIV-infected (OR(mHCT)=1.65, 1.31-2.09; OR(facility)=1.71, 1.37-2.14), while those previously tested were less likely to be HIV-infected (OR(mHCT)=0.75, 0.64-0.88; OR(facility)=0.27, 0.24-0.31). There is an urgent need to promote strategies to identify those who are HIV-infected within MARPs, particularly young women, and to educate and inform them about availability of HIV testing and care services. mHCT, ideally coupled with sexually transmitted infection management, may help to ensure that MARPs access HIV prevention support, and if infected, access care, and treatment.
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The role of hospital-based cancer registries in low and middle income countries-The Nigerian Case Study.
Cancer Epidemiol
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The incidence of cancer continues to rise all over the world and current projections show that there will be 1.27 million new cases and almost 1 million deaths by 2030. In view of the rising incidence of cancer in sub-Saharan Africa, urgent steps are needed to guide appropriate policy, health sector investment and resource allocation. We posit that hospital based cancer registries (HBCR) are fundamental sources of information on the frequent cancer sites in limited resource regions where population level data is often unavailable. In regions where population based cancer registries are not in existence, HBCR are beneficial for policy and planning.
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Cancer incidence in Nigeria: a report from population-based cancer registries.
Cancer Epidemiol
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Cancer has become a major source of morbidity and mortality globally. Despite the threat that cancer poses to public health in sub-Saharan Africa (SSA), few countries in this region have data on cancer incidence. In this paper, we present estimates of cancer incidence in Nigeria based on data from 2 population-based cancer registries (PBCR) that are part of the Nigerian national cancer registry program.
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Clinical features and preliminary studies of virological correlates of neurocognitive impairment among HIV-infected individuals in Nigeria.
J. Neurovirol.
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In Nigeria, the incidence and prevalence of human immunodeficiency virus (HIV)-related neurocognitive impairment (NCI) are unknown and there currently exists little information related to the viral correlates rates of NCI. Therefore, studies were performed to examine the potential utility of applying an established neuropsychological (NP) screening battery and detailed NP testing to detect NCI and correlations with functional impairment and the presence of specific viral signatures among infected subjects. A total of 60 HIV-1 seropositive antiretroviral-naive individuals and 56 seronegative control subjects were administered the International HIV Dementia Scale (IHDS) and assessed for functional impairment using the Karnofsky performance status scale. Fifteen HIV-infected patients and 11 controls were also administered a detailed NP battery. Blood samples from eight infected subjects, three with evidence of NCI, were obtained for molecular analysis of HIV-1 strain. Unadjusted scores on the IHDS showed that, using a recommended total score cutoff of 10, 28.8% of the HIV-1 seropositive and 16.0% of seropositive individuals scored abnormally. Results from testing using the full NP battery showed that, overall, the HIV seropositive group performed worse than the seronegative group, with effect sizes spanning from small (0.25 on the trail making test A) to large (0.82 on action fluency), and an average effect size across the battery of 0.45, which approaches that which has been recorded in other international settings. Sequencing of partial pol amplicons from viral isolates revealed that two of three patients with NCI were infected with subtype G virus and 1 with the circulating recombinant form (CRF)02_AG; all four individuals without NCI were infected with CRF_02AG. These studies demonstrate the utility of the IHDS in identifying cognitive impairment among HIV infected individuals in Nigeria. Future studies aimed at examining the burden of NCI among the population of individuals with HIV-1 infection in Nigeria and which assess the virologic correlates will contribute to the evolving understanding of the pathogenetic factors that underlie this disorder.
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Characterization of acute HIV-1 infection in high-risk Nigerian populations.
J. Infect. Dis.
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Acute phase of human immunodeficiency virus (HIV) infection (AHI) may account for a significant proportion of HIV-1 transmission. We identified and characterized individuals in Nigeria with AHI.
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Safety and immunogenicity of an HIV-1 gag DNA vaccine with or without IL-12 and/or IL-15 plasmid cytokine adjuvant in healthy, HIV-1 uninfected adults.
PLoS ONE
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DNA vaccines are a promising approach to vaccination since they circumvent the problem of vector-induced immunity. DNA plasmid cytokine adjuvants have been shown to augment immune responses in small animals and in macaques.
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