
Pediatric Enhanced Surveillance Study
Human Immunodeficiency Virus (HIV)Acquired Immune Deficiency Syndrome (AIDS)The Pediatric Enhanced Surveillance Study is a three part study of HIV-infected infants and children in South Africa to examine, clinical, immunologic, virologic, metabolic, psychosocial and behavioral outcomes. This study has two parts: (1) comprehensive de-identified records review of all HIV-infected children enrolled in at the pediatric Wellness and ART clinics at the five study sites; and (2) a prospective cohort surveillance study with active consented enrollment with 12-24 months of follow-up. As part of the prospective cohort, the study will aim to collect outcomes on children lost to follow-up, including causes of death through review of death certificates in the clinical chart and through verbal autopsy reports. The study will provide insights into overall outcomes for the larger pediatric patient populations in the province and South Africa. This work is designed in collaboration with the provincial health authorities of the Eastern Cape Department of Health (EC), The International Center for acquired immune deficiency syndrome (AIDS) Care and Treatment Programs (ICAP) South Africa and Center of Disease Control (CDC)-South Africa in support of the South African National ART Program for Children and aims to collect and analyze accurate, relevant and useful information that will be available on children seen at facilities. For the prospective cohort study, we will aim to enroll 400 children newly initiated on ART at 5 health facilities in the Eastern Cape of South Africa who will be actively followed for up to 24 months.

A Phase 1, Randomized, Blinded, Dose-escalation Study of rAAV1-PG9DP Recombinant AAV Vector Coding...
HIV InfectionsThe purpose of this study is to evaluate the safety, tolerability and immunogenicity of rAAV1-PG9DP when administered intramuscularly at different dose levels in healthy male adults.

Feasibility of Using a Structured Daily Diary
HIV InfectionThis protocol explores the feasibility and acceptability of using two daily diary methods to analyze state-dependent variables and psychosocial health outcomes in Human Immunodeficiency Virus (HIV)-positive young men who have sex with men (YMSM). The study will explore the potential of diaries for use in feedback-based interventions.

A Post Marketing Survey Study to Evaluate the Safety and Effectiveness of Prezista
Acquired Immune Deficiency SyndromeThe purpose of this study is to assess the safety data of darunavir in a natural clinical practice.

EFV Pharmacokinetics & Pharmacogenomics in Older HIV-infected Patients
HIV InfectionThe primary purpose of this study is to investigate the steady-state pharmacokinetics of efavirenz in older HIV-infected patients as compared to historical controls; to investigate the relationship of drug exposure to neuropsychiatric side effects and neuropsychological performance; and to explore the role of host polymorphisms in drug metabolism in the older patient.

A Study of Co-infections of HIV-1 and Schistosoma Mansoni and Its Impact on Praziquantel Treatment...
AnemiaIntestinal Helminthiasis4 moreIn this study, it is hypothesized that helminth infections modulate immune responses against HIV-1 infection resulting into increased HIV-1 multiplication, faster progression to AIDS and increased episodes of AIDS-related opportunistic infections. Furthermore, the effect of helminth infections on progression of HIV-1 infection is dependent on helminth infection intensity, host background immunity, nutritional status, demographic factors and socio-economic status. Also, treatment of helminth infections using praziquantel and albendazole among HIV-1 infected individuals will lead to reduction in HIV-1 viral loads, improvement of CD4+ counts, CD4+/CD8+ ratio and Hb levels, improved weight gain and reduction of episodes of HIV-1 related opportunistic infections. In addition, HIV-1 infection is associated with poor anthelminthic treatment outcome as compared to non-HIV infected individuals

Observational Study With Antiretroviral Treated Patients Switching to Nevirapine Plus Two Nucleoside...
HIV InfectionsCollecting data on maintaining anti-retroviral activity (quantitative HIV RNA determination) and immunological activity (CD4 cells) after switching from protease inhibitor or NNRTI to Nevirapine (Viramune®) and collecting of routinely observed laboratory data on lipids, and liver enzymes.

Observational Study in Patients With HIV Infection Type 1 After Switching to a Viramune®-Containing...
HIV InfectionsObservational study to collect data on maintaining anti-retroviral activity (quantitative HIV RNA determination) and immunological activity (CD4 cells) despite switching from protease inhibitor to nonnucleoside reverse transcriptase inhibitor (NNRTI) (Viramune®).

Drug Use Investigation of Kaletra Tablets (Once Daily Administration) on Patients With HIV-infection...
Human Immunodeficiency Virus InfectionThis study of Kaletra (Lopinavir (LPV)/Ritonavir (RTV)) tablets will be conducted to clarify the following with regard to treatment with this drug: Incidence and conditions of occurrence of adverse reactions in the clinical setting Factors that may affect the safety and effectiveness of Kaletra (QD)

Post-marketing Safety Surveillance Program in Human Immunodeficiency Virus (HIV)-Infected Children...
HIV InfectionThe purpose of this study is to monitor adverse events in HIV-infected children <18 years old who are exposed to Atazanavir in a real-world setting in Europe.