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You are here : Clinical Trials
Saturday , October , 19 2019

ESRU Clinical Trials

Please see below a list of all the studies we are involved with.
ESRU Investigator Initiated Studies

Clinical relevance of Nevirapine resistance for the treatment of HIV-infected women and children exposed to Nevirapine through prevention of mother-to-child-transmission (PMTCT) programs. (NEVEREST Protocol 1). The study is a non-experimental study of virologic response to an NVP-containing treatment regimen among HIV-infected women exposed to NVP 18-30 months previously compared to a matched group of HIV-infected women not exposed to NVP.

Principal Investigators: Prof Ashraf Coovadia; Prof Louise Kuhn

ESRU only or Multicentre: ESRU only

Date Study Closed: May 2009

Clinical relevance of Nevirapine resistance for the treatment of HIV-infected women and children exposed to Nevirapine through prevention of mother-to-child-transmission (PMTCT) programs. (NEVEREST Protocol 2) ). The aim is to evaluate a possible strategy to preserve nevirapine (NVP) as a component of treatment regimens for young children when exposure to NVP as a part of a PMTCT prophylaxis regimen has already occurred.

Principal Investigators: Prof Ashraf Coovadia; Prof Louise Kuhn

ESRU only or Multicentre: ESRU only

Date Study Closed: Jun 2010

An unblinded randomized clinical trial to evaluate a simplification, protease-inhibitor(PI)-sparing treatment strategy among nevirapine (NVP)-exposed HIV-infected children treated initially with lopinavir/ritonavir(LPV/r).

Principal Investigators: Prof Ashraf Coovadia; Prof Louise Kuhn

ESRU only or Multicentre: ESRU only

Date Study Closed: On going

Childhood HAART Alterations in Normal Growth, Genes and aGing Evaluation Study (CHANGES) To study the chronic effects of growing up with HIV. We will prospectively follow the re-enrolled HIV-infected children and collect standardized clinical data on co-morbidities, toxicities and complications, laboratory data on HIV-related parameters and blood samples and other specimens for special studies at 6-month intervals for the duration of the grant

Principal Investigators: Prof Ashraf Coovadia, Prof Louise Kuhn, Dr Stephen Arpadi

ESRU only or Multicentre: Multicentre

Date Study Closed: On going

Early Infant Diagnosis of vertically infected infants in low resource settings

Principal Investigators: Prof Gayle Sherman

ESRU only or Multicentre: ESRU only

Date Study Closed: Dec 2003

Scaling up infant diagnosis using rapid HIV tests on oral fluid and blood

Principal Investigators: Prof Gayle Sherman

ESRU only or Multicentre: Multicentre

Date Study Closed: Mid 2008

Strengthening Linkages Between Services Decreased Delays in Initiating Antiretroviral Treatment for Pregnant Women

Principal Investigators: Dr Karin van der Merwe

ESRU only or Multicentre: ESRU only

Date Study Closed: Jul 2009

Earlier Diagnosis of HIV infection in infants

Principal Investigators: Prof Gayle Sherman

ESRU only or Multicentre: ESRU only

Date Study Closed: Dec 2010

Evaluation of the first 4th generation Rapid test (Determine Combo) in an antenatal setting

Principal Investigators: Prof Gayle Sherman

ESRU only or Multicentre: ESRU only

Date Study Closed: Jul 2010

Evaluation of the first 4th generation Rapid test (Determine Combo) for EID of HIV-exposed infants

Principal Investigators: Prof Gayle Sherman

ESRU only or Multicentre: ESRU only

Date Study Closed: Dec 2011

Improving follow-up and HIV testing rates of exposed infants through a support package, tracking and SMSs offered to mothers after birth

Principal Investigators: Dr Karl Technau

ESRU only or Multicentre: ESRU only

Date Study Closed: Feb 2011

Finding Infants with HIV Disease: Evaluation of Resistance, PMTCT Failures and Linking Access to Care (The FInHDER Study)

Principal Investigators: Prof Ashraf Coovadia & Prof Louise Kuhn

ESRU only or Multicentre: Multicentre

Date Study Closed: Dec 2011

Infant HIV Diagnoses in South Africa – Improving outcomes through point of care testing at birth the SAMBA baby and mothers study (BAMS)

Principal Investigators: Dr Karl Technau

ESRU only or Multicentre: ESRU only

Date Study Closed: On going

Investigator Initiated Studies Where ESRU Worked/Is Working In Collaboration With Other Sites (not network)

Protective Immunity and Perinatal Exposure (PIPE)Assessment of transmission factors in HIV-infected mother infant pairs

Principal Investigators: Prof Caroline Tiemessen , Prof Coovadia (Site PI)

ESRU only or Multicentre: Two sites PHRU (Bara)ESRU

Date Study Closed: 2005

An open label, sequential non-randomised pharmacokinetics study comparing lopinavir plasma exposure when given as lopinavir superboosted with ritonavir (1:1 ratio) in the presence of rifampicin or lopinavir boosted with ritonavir (4:1 ratio) in the absence of rifampicin in Human Immune Deficiency Virus (HIV) and tuberculosis (TB) co-infected children in South Africa

Principal Investigators: Dr Helena Rabie , Prof Ashraf Coovadia (Site PI)

ESRU only or Multicentre: Two sites Kidcru (CPT)ESRU

Date Study Closed: On going

Saving Lives at Birth (SLAB) Performance of an Innovative, Instument-Free, Low-Cost, Point-of-Care CD4 (Visitect CD4) Test among HIV-Infected Pregnant and Postpartum Women: Beta Testing Protocol

Principal Investigators: Dr Stanley Luchters , Prof Ashraf Coovadia (Site PI)

ESRU only or Multicentre: ESRU Kenyan Site

Date Study Closed: N/A

Network Trials

Assessment of Safety and Toxicity Among Infants Born to HIV-1-Infected Women Enrolled in Antiretroviral Treatment Protocols in Diverse Areas of the World

Principal Investigators: Dr Francesca Conradie

ESRU only or Multicentre: Multicentre

Date Study Closed: May 2010

Breastfeeding Version of the PROMISE Study (Promoting Maternal and Infant Survival Everywhere) A Multicenter, US Domestic and International Trial of the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Group

Principal Investigators: Prof Ashraf Coovadia (Investigator of Record –IoR)

ESRU only or Multicentre: Continuing at Shandukani site

Date Study Closed: On going

Formula Feeding Version of the PROMISE Study (Promoting Maternal and Infant Survival Everywhere)

Principal Investigators: Prof Ashraf Coovadia (Investigator of Record –IoR)

ESRU only or Multicentre: Multicentre

Date Study Closed: N/A

Maternal and Infant Monitoring for Evidence of Toxicity Related to Tenofovir Exposure: The Bone and Kidney Health Substudy of the IMPAACT 1077 PROMISE Protocol. A Nested, comparative substudy of bone, renal and growth outcomes of subjects randomized to maternal TDF or no maternal TDF during pregnancy or during breastfeeding in 1077BF and 1077FF

Principal Investigators: Prof Ashraf Coovadia (Investigator of Record –IoR)

ESRU only or Multicentre: Multicentre

Date Study Closed: Continuing at Shandukani site

Sepsis PRevalence OUtcomes and Therapies An International Point Prevalence Study of Pediatric Severe Sepsis and Septic Shock

Principal Investigators: Dr Gary Reubenson

ESRU only or Multicentre: Multicentre

Date Study Closed: On going

Pharma Trials

A Study of the Pharmacokinetics of Atazanavir (ATV)/Ritonavir (RTV) Administered as Part of HAART Therapy in HIV-1 Infected Pregnant Women

Principal Investigators: Dr Francesca Conradie

ESRU only or Multicentre: Multicentre

Date Study Closed: Aug 2009

A 48 Week, Phase II, Non-Comparative, Open-Label, Multi-Cohort, Multicentre Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of GW433908/Ritonavir

Principal Investigators: Prof Ashraf Coovadia

ESRU only or Multicentre: Multicentre

Date Study Closed: Mar 2013

A prospective single arm, open-label, international, multicenter study to evaluate the safety, efficacy and pharmacokinetics of atazanavir (ATV) powder with ritonavir (RTV) with optimal background therapy. (Pediatric atazanavir International Clinical Evaluation: the PRINCE I study)

Principal Investigators: Dr Renate Strehlau

ESRU only or Multicentre: Multicentre

Date Study Closed: On going

A prospective single arm, open-label, international, multicenter study to evaluate the safety, efficacy and pharmacokinetics of atazanavir (ATV) powder with ritonavir (RTV) with optimal background therapy (Pediatric atazanavir International Clinical Evaluation: the PRINCE II study)

Principal Investigators: Prof Ashraf Coovadia

ESRU only or Multicentre: Multicentre

Date Study Closed: On going

A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Single Tablet Regimen (STR)

Principal Investigators: Dr Renate Strehlau

ESRU only or Multicentre: Multicentre

Date Study Closed: On going

A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/ Cobicistat/ Emtricitabine/ Tenofovir Alafenamide(E/C/F/TAF) Single Tablet Regimen (STR)

Principal Investigators: Dr Renate Strehlau

ESRU only or Multicentre: Multicentre

Date Study Closed: N/A

A Phase 2/3 Multicenter, Open-Label, Multicohort, Two-Part Study Evaluating the Pharmacokinetics(PK), Safety, and Antiviral Activity of Elvitegravir (EVG) Administered with a Background Regimen (BR) Containing a Ritonavir-Boosted Protease Inhibitor (PI/r)

Principal Investigators: Dr Renate Strehlau

ESRU only or Multicentre: Multicentre

Date Study Closed: Ongoing

Research done by ESRU Staff as Part of Academic Advancement

Early Infant Diagnosis of vertically infected infants in low resource settings

Researcher: Prof Gayle Sherman

Acacemic Purpose: PhD in Medicine

Date Study Closed: Dec 2003

Can a routine peri-partum HIV counselling and testing service for women improve access to HIV prevention, early testing and treatment of children?

Researcher: Dr Karl Technau

Acacemic Purpose: Master of Science in Medicine by dissertation

Date Study Closed: Sep 2008

Diagnosis and monitoring of HIV in infants: Investigating the first fourth generation rapid test and two viral load technologies for use in the South African setting

Researcher: Mrs Kapila Bhowan

Acacemic Purpose: Masters of Science in Medicine

Date Study Closed: On going

The Impact of In-Utero Highly Active Antiretroviral therapy (HAART) exposure on infant outcomes

Researcher: Dr Karin van der Merwe

Acacemic Purpose: Masters of Science in medicine by dissertation

Date Study Closed: 2010

Identifying Interventions to Improve Outcomes of the South African Prevention of Mother-to-Child Transmission Programme

Researcher: Ms Rivka Lilian

Acacemic Purpose: Master of Science in Medicine

Date Study Closed: 2013

Neurodevelopmental Delays In Children With Perinatally Acquired Human Immunodeficiency Virus Infection, With Respect To Antiretroviral Therapy Initiation And Virological Suppression

Researcher: Dr Renate Strehlau

Acacemic Purpose: Master of Science in Medicine in Child Health Neurodevelopment

Date Study Closed: 2013

Research for Academic Advancements by Non-ESRU Staff Facilitated by ESRU as Within the Unit

Executive Function in HIV Positive Adolescents on Antiretroviral Treatment in Johannesburg, South Africa

Researcher: Mrs Urvashi Maganlal

Acacemic Purpose: MA (Neuropsychology)

Date Study Closed: Feb 2013

Visuospatial Abilities of HIV Positive Adolescents on Antiretroviral Treatment in South Africa

Researcher: Mr Daniel Greenslade

Acacemic Purpose: MA (Neuropsychology)

Date Study Closed: Feb 2013

Psychomotor Functioning of HIV Positive Adolescents on Antiretroviral Treatment in Johannesburg, South Africa

Researcher: Ms Stephanie Macilwaine

Acacemic Purpose: MA (Neuropsychology)

Date Study Closed: Feb 2013

Attention and Concentration Functions in HIV-Positive Adolescents who are on Antiretroviral Treatment

Researcher: Mrs Jessica Fry

Acacemic Purpose: MA (Neuropsychology)

Date Study Closed: Feb 2013

Verbal Fluency and Vocabulary in Adolescents living with HIV-1 in South Africa

Researcher: Ms Cindy van Wyk

Acacemic Purpose: MA (Neuropsychology)

Date Study Closed: Feb 2013

Verbal Fluency and Vocabulary in Adolescents positive adolescents receiving antiretroviral treatment.

Researcher: Ms Shona Fraser

Acacemic Purpose: MA (Neuropsychology)

Date Study Closed: Feb 2013

The neurodevelopment of HIV positive infants on HAART compared to HIV exposed but uninfected infants

Researcher: Ms Nicole Whitehead

Acacemic Purpose: Master of Science (Physiotherapy)

Date Study Closed: Sep 2011

Descriptive study of HIV drug resistance genotype testing in a public sector paediatrics population in Johannesburg

Researcher: Dr Phocas Ngabire

Acacemic Purpose: Masters of Medicine (Paediatrics)

Date Study Closed: On going

Antiretroviral therapy in HIV infected children – a secondary analysis of growth parameters associated with age at initiation

Researcher: Dr Lethabo Machaba

Acacemic Purpose: Masters of Medicine (Paediatrics)

Date Study Closed: On going

Characteristics and treatment outcomes of the currently active population at a large paediatric HIV clinics

Researcher: Dr Basetsana Maroane

Acacemic Purpose: Masters of Medicine (Paediatrics)

Date Study Closed: On going

An investigation of peripheral neuropathy in children who are infected with HIV

Researcher: Ms Natalie Alice Benjamin

Acacemic Purpose: Masters of Medicine (Paediatrics)

Date Study Closed: On going

The Impact of External Factors on Neuropsychological Performance

Researcher: Ms Kim Harris

Acacemic Purpose: BA General Psychology (Honours)

Date Study Closed: Nov 2012

The development of a visual-motor treatment programme for pre-school HIV-infected children with visual motor intefration difficulties

Researcher: Mrs Ramona Odejayi

Acacemic Purpose: Master of Science (Occupational Therapy)

Date Study Closed: 2013

The Neuropsychological Profile of HIV Positive Adolescents on Anti-Retroviral Treatment in Johannesburg, South Africa

Researcher: Ms Kelly Holland

Acacemic Purpose: MA (Research Psychology) by dissertation

Date Study Closed: On going

A Comparison of Working Memory Profiles in HIV positive and HIV Uninfected Exposed Children The study aims to investigate and compare the working memory profiles of children

Researcher: Mrs Robyn Milligan

Acacemic Purpose: PhD Psychology

Date Study Closed: On going

Oro-facial manifestations of the Human Immunodeficiency Virus (HIV) in paediatric patients

Researcher: Dr Avni Bhula

Acacemic Purpose: Masters of Science in Dentistry

Date Study Closed: NA

Playfulness and environmental supportiveness in Human Immunodeficiency Virus (HIV)-infected children

Researcher: Ms Shailendra Njitimana

Acacemic Purpose: Master of Science (Occupational Therapy)

Date Study Closed: NA