IMPAACT TRIALS
Completed Trials:
369
A phase I/II open label study of Nitazoxanide for the treatment of Cryptosporidium Parvum in HIV infected infants, children and adolescents.
Duration: January 2004 – June 2005
P1041
A randomized, double blind, placebo controlled trial to determine the efficacy of Isoniazid (INH) in preventing Tuberculosis disease and latent Tuberculosis infection among South African infants with perinatal exposure to HIV.
Duration: Feb 2004 – June 2008
P1043
Phase II randomized trial of the safety and efficacy of three neonatal regimes for prevention of intrapartum HIV-1 transmission.
Duration: 2007 – December 2010
ATN 024 I
A randomized, open-label trial of Three Hepatitis B vaccination schemas in HIV- Positive Youth for International Sites.
Duration: 2006 – 2007
P1031
The study evaluated the feasibility, rate of acceptance and acceptability of voluntary HIV counseling and rapid testing among pregnant woman with undocumented HIV serostatus who present for delivery and to compare intrapartum versus postpartum rapid testing with respect to these measures. Examined the rate of acceptance of an ability to administer antiretroviral prophylaxis prior to delivery to women who are identified as HIV seropositive through intrapartum rapid HIV testing and to their infants. Examined the rate of acceptance of and ability to administer antiretroviral prophylaxis to infants born to women who are identified as seropositive through postpartum rapid HIV testing.
Duration: October 2004 – September 2006
P1041 Substudy (DACS 646)
Predictors of TB disease in HIV exposed uninfected and HIV infected children within P1041. This sub analysis is looking at predictions of TB disease such as the impact of passive smoking in developing TB disease in children exposed and infected with HIV.
Duration: March 2009 – May 2010
Current Trials:
P1066
P1066 is a study looking at a new antiretroviral agent, Raltegravir which is an integrase inhibitor which works by blocking integrase, a protein that HIV needs to enter human cells and make more copies of itself.
The study will look at the correct dose to give to infants and children and will also look at the safety and efficacy of Raltegravir. Inclusion age criteria: 4 weeks to < 6 years
Duration: July 2010 – ongoing
P1070
P1070 is a study looking at using an antiretroviral called efavirenz in children less than 3 years of age. Efavirenz is a type of antiretroviral known as a non-nucleoside reverse transcription inhibitor (NNRTI). It is presently not registered for use in children < 3 years. This study will look at the correct dose needed in infants and children and will also look at the safety and efficacy of efavirenz.
It is also looking at giving efavirenz to children who need TB treatment in addition to ARVs. Inclusion age criteria: ≥ 3 months to ≤ 3 years.
Duration: 16 March 2010 - ongoing
P1073
P1073 is a study looking at a condition called Immune Reconstitution Inflammatory Syndrome (IRIS). IRIS can be seen shortly after starting ARVs and it happens when the immune system recovers too quickly resulting in inflammation. This inflammation can cause severe symptoms that could be mistaken for an HIV-associated illness. The IRIS study will specifically be looking at inflammation associated with prior or present undetected BCG and or TB disease. Inclusion criteria: Infants and children ≥ 4 weeks - ≤ 5 years who are about to initiate ARVs
Duration: 2 February 2010 - ongoing
P1060
This is a study comparing the response to 2 ARV regimes of HIV infected infants who have and have not previously received a single dose of Nevirapine for the prevention of mother – to – child – transmission.
Duration: November 2008 – ongoing
P1084
Maternal and Infant Monitoring for Evidence of Toxicity Related to Tenofovir Exposure: The Bone and Kidney Health Substudy of the IMPAACT 1077 PROMISE Protocol (Promoting Maternal and Infant Survival Everywhere)
Duration: May 2011 - ongoing
P1077 - Promise
The 1077 protocol is designed to address in the integrated and comprehensive fashion 4 critical questions currently facing HIV infected pregnant and postpartum women and their infants.
Duration: May 2011 – ongoing
P1083
A Phase II / III trial of Lopinavir / Ritonavir dose according to the WHO Pediatric Weight band dosing guidelines.
Duration: 2010 - ongoing
P1113 / Aeras C-015-404
Phase I/II, Safety and Immunogenicity STUDY of a Recombinant Protein Tuberculosis Vaccine (AERAS-404) in BCG-Primed Infants
Duration: 2013 - ongoing
Trials Coming Soon:
P1091
Administration of Polysaccharide or conjugated pneumococcal vaccines to HIV – Infected pregnant women: safety and magnitude, persistence, and transplacental transfer of vaccine – serotype pneumococcal anti – capsular antibodies.
P1078
A randomized double – blind placebo – controlled trial to evaluate the safety of immediate (antepartum – initiated) versus deferred (postpartum – initiated) isonaized preventive therapy among HIV – infected woman in high TB incidence settings.
P1104
Longitudinal Developmental and Neuropsychological Assessments of HIV-Infected participants of P1060 and HIV- Uninfected Controls.
P1106
Phamacokinetic characteristics of antiretrovirals, tuberculosis medicins and Trimethoprim – Sulfamethoxazole in low birth weight infants.
