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URL	Public Title	Trial Number (Registration Number)	Universal Trial Number (UTN)	Other ID	Scientifc Title	Trial Status	Brief BriefSummary	Disease Or Health Condition	Intervention Treatment	Groups & Interventions Treatment	Registration Type	Study Type	Study phase	Study Design	Purpose of Trial/Study	Target Size	Recruitment Status	Intervention	Key Inclusion Criteria	Key Exclusion Criteria	Minimum Age	Maximum Age	Gender	Age Category	Can healthy volunteers participate	Primary Outcome	Secondary Outcome	Countries of recruitment	Recruitment Centre	Trial start date	Trial end date	Date of last data collection Actual	Reason - if recruiting stopped/withdrawn	Ethics Review Committee	Funding Source	Primary Study Sponsor	Secondary Study Sponsor	Collaborators	Representative manager - multi center joint research	Principal Investigator/Scientific Queries	Public Queries Contact	Other Contact Person Affiliation
URL	Double dose Kaletra in children	PACTR2008060000852767			Doubling The Dose Of Lopinavir/Ritonavir As An Approach To Using Kaletra┬« In TB...	Registered in accordance with WHO and ICMJE standards	Comparing Lopinavir concentrations in HIV-infected children with or without TB	Infections and Infestations	Experimental Group	Lopinavir (LPV)/Ritonavir (RTV)	CCT	CCT	Treatment: Drugs	Treatment: Drugs	Treatment: Drugs	0	Stopped early/ terminated	Non-randomised	HIV-infected children with and without TB (controls) aged 6 months to 15 years. ...	ALT > 10X the upper limit of normal (grade 3 or 4). Known renal, hepatic or ch...			Both			Primary Outcome	Secondary Outcome	South Africa	Red Cross Childrens Hospital	01-08-07	02-08-08			17-10-06	European and Developing Countries Clinical Trials Partnership	University of Cape Town		Dr James Nuttall		Helen McIlleron	Public Enquiries	Scientific Enquiries
URL	An international multicentre controlled clinical trial to evaluate high dose rif...	PACTR2008060000861040			An international multicentre controlled clinical trial to evaluate high dose rif...	Registered in accordance with WHO and ICMJE standards	Current TB treatment involves taking drugs daily for 6-8 mnths. Although drugs f...	Infections and Infestations	Experimental Group	Rifapentine	CCT	CCT	Treatment: Drugs	Treatment: Drugs	Treatment: Drugs	1100	Completed	Randomised	1. Newly diagnosed pulmonary tuberculosis 2. Two sputum specimens positive for ...	1. Has any condition (except HIV infection) that may prove fatal during the stud...			Both			Primary Outcome	Secondary Outcome	Zimbabwe	Biomedical Research and Training Institute	26-07-07	31-07-12	31-07-12		17-03-08	Wellcome Trust	St Georges Hospital Medical School trading as St Georges University of London		Janneke van Dijk		Amina Jindani	Public Enquiries	Scientific Enquiries
URL	Options Western Cape	PACTR2008060000883662			Options Western Cape: Implementation and evaluation of a positive prevention int...	Registered in accordance with WHO and ICMJE standards	The focus of this study is the implementation and evaluation of a clinic-based b...	Infections and Infestations	Experimental Group	Options for Health	CCT	CCT	Prevention	Prevention	Prevention	0	Stopped early/ terminated	Randomised	Patients over the age of 18 years Patients who know their HIV status Patients ...	Patients on ART for more than 3 months HIV-positive patients not on ART			Both			Primary Outcome	Secondary Outcome	South Africa	80 patients will be recruited from each of 30 ARV clinics in the Cape Town metro...	01-04-08	02-04-09			20-12-07	Centers for Disease Control and Prevention	Human Sciences Research Council		University of the Western Cape		Mickey Chopra	Public Enquiries	Scientific Enquiries
URL	Pilot study of additional Prednisone and Mycobacterium w vaccine in tuberculosis...	PACTR2008060000892906			A Pilot Trial Of Adjunctive Prednisone And Mycobacterium W Immunotherapy In Tube...	Registered in accordance with WHO and ICMJE standards	Pericardial tuberculosis is a severe type of tuberculosis that lead to death of ...	Infections and Infestations	Experimental Group	Mycobacterium w immunotherapy	CCT	CCT	Treatment: Drugs	Treatment: Drugs	Treatment: Drugs	1400	Completed	Randomised	Confirmed pericardial effusion on echocardiography Evidence of definite or prob...	Presence of an alternative cause of pericardial disease, e.g. penetrating chest ...			Both			Primary Outcome	Secondary Outcome	Mozambique	Instituto Do Coracao	01-01-09	28-02-12	28-02-14		31-07-07	University of Cape Town	University of Cape Town		Professor Marek Smieja		Bongani Mayosi	Public Enquiries	Scientific Enquiries
URL	Safety and immunogenicity of a candidate HIV-1 vaccine, MVA.HIVA, administered t...	PACTR2008120000904116			Evaluation of safety and immunogenicity of a candidate HIV-1 vaccine, MVA.HIVA, ...	Registered in accordance with WHO and ICMJE standards	Aim: to develop vaccine for prevention of mother-to-child transmission of HIV-1 ...	Infections and Infestations,Paediatrics	Experimental Group	MVA.HIVA	RCT	RCT	Prevention: Vaccines	Prevention: Vaccines	Prevention: Vaccines	48	Completed	Randomised	Healthy infants, 12 weeks of age, with weight for age z-scores within 2 standard...	Acute disease at the time of vaccination (acute disease is defined as the presen...			Both			Primary Outcome	Secondary Outcome	Gambia	Sukuta Health Centre	15-12-09	01-10-10	01-10-10		26-06-08	EDCTP	Medical Research Council UK		Marie Reilly		Tomas Hanke	Public Enquiries	Scientific Enquiries
URL	4 ACT for uncomplicated malaria in African children	PACTR2009010000911750		NCT00393679	Evaluation of 4 Artemisinin-Based Combinations for Treating Uncomplicated Malari...	Registered in accordance with WHO and ICMJE standards	The main objective is to compare the safety and efficacy of 4 artemisinin-based ...	Infections and Infestations	Experimental Group	dihydroartemisinin-piperaquine	CCT	CCT	Treatment: Drugs	Treatment: Drugs	Treatment: Drugs	0	Completed	Randomised	1. Weight > 5 kg; 2. Monoinfection with P. falciparum and a parasitaemia of 2,00...	1. Participation in any other investigational drug study (antimalarial or others...			Both			Primary Outcome	Secondary Outcome	Zambia	The Tropical Diseases Research Centre	28-08-07	29-08-08			16-10-06	EDCTP	Institute Tropical Medicine		Modest Mulenga		Umberto D'Alessandro	Public Enquiries	Scientific Enquiries
URL	Safety and immunogenicity of a candidate HIV-1 vaccine, MVA.HIVA, administered t...	PACTR2009010001152787			An open randomized phase I/II study evaluating safety and immunogenicity of a ca...	Registered in accordance with WHO and ICMJE standards	This is an open randomized phase I/II study of a candidate HIV vaccine, MVA.HIVA...	Infections and Infestations,Paediatrics	Experimental Group	MVA.HIVA	RCT	RCT	Prevention: Vaccines	Prevention: Vaccines	Prevention: Vaccines	72	Completed	Randomised	Mother Inclusion Criteria a. Second or third trimester of pregnancy, as determi...	Mother Exclusion Criteria a. WHO stage 3 or 4 disease progression as determined ...			Both			Primary Outcome	Secondary Outcome	Kenya	Kenyatta National Hospital	01-02-10	01-05-12			27-11-08	European and developing countries clinical trials partnership	Medical Research Council UK		Walter Jaoko		Tomas Hanke	Public Enquiries	Scientific Enquiries
URL	HIVIS03	PACTR2009040001075080			A phase I/II trial to assess safety & immunogenicity of a plasmid DNA-MVA prime ...	Registered in accordance with WHO and ICMJE standards	Following work in TANSWED Programme funded by Sida/SAREC, in 2001 a EU funded HI...	Infections and Infestations	Experimental Group	Priming with intramuscular DNA, Boosting with intramuscular MVA	CCT	CCT	Prevention: Vaccines	Prevention: Vaccines	Prevention: Vaccines	0	Closed to recruitment,follow-up continuing	Randomised	18-40 years Willing to be counseled & HIV tested Negative HIV Ag/Ab ELISA Infor...	Active TB/other systemic infection Positive HBsAg Active syphilis Immunodeficien...			Both			Primary Outcome	Secondary Outcome	United Republic of Tanzania	Muhimbili	20-02-07	21-02-08			30-01-06	Swedish Embassy through Treasury & Ministry of Health, Tanzania	Muhimbili University of Health and Allied Sciences (MUHAS)		Muhimbili National Hospital (MNH)		Fred Mhalu	Public Enquiries	Scientific Enquiries
URL	Optimization of tuberculosis and HIV co-treatment in Africa	PACTR2009040001261177			Pharmacokinetic, pharmacogenetic aspects on drug-drug interactions between rifam...	Registered in accordance with WHO and ICMJE standards	Concomitant HIV and TB treatment is complicated due to interaction between rifam...	Infections and Infestations	Experimental Group	Arm-2: HIV and Tuberculosis infected	CCT	CCT	Treatment: Drugs	Treatment: Drugs	Treatment: Drugs	0	Recruiting	Non-randomised	Inclusion criteria for ARM-1 - HIV-infected patients > 18 years of age - Activ...	Exclusion Criteria for ARM-1 - Haemoglobin < 8 gm/dL - Presence of persistent d...			Both			Primary Outcome	Secondary Outcome	Ethiopia	Arada Health Center	09-01-08	31-12-12			10-05-07	The European & Developing Countries Clinical Trials Partnership (EDCTP)	Karolinska institutet		Professor Ferdinand Mugusi, MD, PhD		Eleni Aklillu	Public Enquiries	Scientific Enquiries
URL	High RIF	PACTR2009060001493909		NCT00760149	Pharmacokinetics and -dynamics of high versus standard dose rifampicin in patien...	Registered in accordance with WHO and ICMJE standards	The current tuberculosis (TB) treatment is lengthy and complex, resulting in pro...	Infections and Infestations	Experimental Group	Higher dose rifampicin(900 mg)	RCT	RCT	Treatment: Drugs	Treatment: Drugs	Treatment: Drugs	150	Completed	Randomised	1. Participant has newly diagnosed pulmonary tuberculosis, confirmed by a positi...	1. Participant has been treated with anti-tuberculosis drugs during the past thr...	18 Year(s)	65 Year(s)	Both			Primary Outcome	Secondary Outcome	United Republic of Tanzania	Kibong'oto National Tuberculosis Centre (KNTH)	01-09-09	31-01-12	31-01-12		07-12-07	European & Developing Countries Clinical Trials Partnership (EDCTP)	African Poverty Related Infection Oriented Research Initiative (APRIORI)		Kilimanjaro Christian Medical Centre (KCMC)		Rob Aarnoutse	Public Enquiries	Scientific Enquiries

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