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NCT ID: NCT01818258 Completed - HIV Positive Clinical Trials

IMPAACT P1092: Steady State PK in Malnourished HIV Infected Children

Start date: October 26, 2015
Phase: Phase 4
Study type: Interventional

Children living with HIV from sub-Saharan Africa often present with severe malnutrition. In severe malnutrition, metabolic and/or gut structural derangement may lead to inadequate antiretroviral (ARV) absorption and/or erratic drug levels. The greater surface area to weight ratio in severely malnourished children could also place them at higher risk of under dosing compared to children with mild to moderate malnutrition. However, limited data are available on the pharmacokinetics of ARVs in severely malnourished children. This study addressed this critical gap in knowledge by evaluating the PK of zidovudine (ZDV), lamivudine (3TC), and lopinavir/ritonavir (LPV/r) in severely malnourished children living with HIV, compared to children with normal nutrition to mild malnutrition living with HIV.

NCT ID: NCT01811836 Completed - Enteropathy Clinical Trials

Zinc Resistant Starch Project

Start date: March 2013
Phase: N/A
Study type: Interventional

Broad - to examine the result of feeding RS to 3-5 year old rural Malawian children on zinc homeostasis and environmental enteropathy (EE). Specific - 1. To measure zinc status using a dual zinc stable isotope assay before and after administering resistant starch (RS) in 20 children. 2. To measure intestinal function using a site-specific sugar absorption test before and after administering RS in 20 children. 3. To determine the relationship between RS and zinc homeostasis. 4. To determine the relationship between RS and environmental enteropathy.

NCT ID: NCT01790048 Completed - Malnutrition Clinical Trials

Whey Permeate Study

Start date: February 2013
Phase: N/A
Study type: Interventional

This is a prospective, randomized, double-blinded, controlled clinical effectiveness trial of two supplementary foods in the treatment of MAM. Specific Aim 1: Test the effectiveness of two supplementary foods, whey RUSF and soy RUSF, in the treatment of MAM in 6-59 month old children in a 12-week home-based supplementary feeding program. Hypothesis: The proportion of children who recover receiving either soy or whey RUSF will differ by no more than three percent.

NCT ID: NCT01789177 Completed - Clinical trials for Postoperative Complications

Use of Disposable Spirometer for Recovery of Pulmonary Function

Start date: January 2013
Phase: N/A
Study type: Interventional

We hypothesize that the addition of modified incentive spirometry to standard postoperative chest physiotherapy will be associated with faster return to baseline/predicted pulmonary function and fewer postoperative pulmonary complications in patients following laparotomy.

NCT ID: NCT01682395 Completed - Intestinal Volvulus Clinical Trials

Best Management of Sigmoid Volvulus: A Prospective Randomized Trial

Start date: February 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to obtain a better understanding of the best management of left-sided colonic emergencies.

NCT ID: NCT01660672 Completed - Epilepsy Clinical Trials

Enteral Levetiracetam For Seizure Control In Pediatric Cerebral Malaria

LVT1
Start date: January 2013
Phase: Phase 1/Phase 2
Study type: Interventional

Pediatric cerebral malaria (CM) affects more than 3 million children each year killing ~20% and leaving one third of survivors with long term neurologic and psychiatric sequelae. Seizures occur commonly with CM and are associated with an increased risk of death and neuropsychiatric disabilities. In this Malawi-based, dose- escalation, safety and feasibility study of enteral levetiracetam in pediatric CM, the investigators will lay the groundwork for future efficacy studies aimed at improving seizure control and ultimately decreasing the neurologic morbidity of pediatric CM.

NCT ID: NCT01650558 Completed - HIV Clinical Trials

Daily Trimethoprim-sulfamethoxazole or Weekly Chloroquine Among Adults on ART in Malawi

TSCQ
Start date: November 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if there is a benefit to taking trimethoprim-sulfamethoxazole (TS) as prophylaxis among HIV positive adults who have viral load suppression and a good clinical response on anti-retroviral therapy (ART). If there is a benefit, then is it due to antimalarial or antibacterial properties. The investigators hypothesize that there will be a long-term benefit on survival and disease control in the context of prophylaxis and that the benefit will largely be attributed to prevention of malaria. The main study hypothesis is that 1)TS and chloroquine (CQ) will decrease the rates of morbidity and mortality among adults after 6 or more months of ART and 2) CQ prophylaxis will be associated with more prolonged viral suppression and higher CD4 cell counts than TS prophylaxis or no prophylaxis.

NCT ID: NCT01641367 Completed - HIV-1 Infection Clinical Trials

A5288/MULTI-OCTAVE: Management Using Latest Technologies to Optimize Combination Therapy After Viral Failure

MULTI-OCTAVE
Start date: February 22, 2013
Phase: Phase 4
Study type: Interventional

The study was done to: - test a strategy of using a resistance test to choose anti-HIV drugs - see how well combinations of new anti-HIV drugs work to lower HIV infection - see if taking new anti-HIV drugs together is safe and tolerable - see if text messages improve people's anti-HIV drug-taking behavior (only at sites participating in the adherence study) - in people taking certain combinations of anti-HIV drugs with an anti-TB drug, compare how these drugs act in the body - to see how people do after they stop having frequent clinic visits as part of a research study

NCT ID: NCT01637558 Completed - HIV Clinical Trials

Optimal Dosing of 1st Line Antituberculosis and Antiretroviral Drugs in Children (a Pharmacokinetic Study)

DATiC
Start date: November 2012
Phase: Phase 4
Study type: Interventional

The aims of this project are to: 1. To evaluate the pharmacokinetics of first line antituberculosis drugs (isoniazid, rifampicin, pyrazinamide and ethambutol) when applying the 2010 WHO/IUATLD dosing guidelines across pediatric populations (0-12 years of age, HIV infected and uninfected, and with varied nutritional status) in Cape Town, South Africa and Blantyre, Malawi. 2. To evaluate an 8-hourly weight band-based dosing strategy for lopinavir/ritonavir using the commercially available lopinavir/ritonavir (4:1 ratio) in children in South Africa receiving rifampicin-based antituberculosis treatment. 3. To evaluate the pharmacokinetics of nevirapine in children in Malawi receiving rifampicin-based antituberculosis treatment.

NCT ID: NCT01632891 Completed - HIV-1 Infection Clinical Trials

Comparing PI-Based to a nNRTI-based ART for Clearance of Plasmodium Falciparum Parasitemia in HIV-Infected

Start date: January 10, 2014
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study was to see if antiretroviral therapy (ART) is safe and works at getting rid of malaria in blood and to see whether one type of ART is better than another. This study may offer information for further research in looking at whether ART plays a role in the prevention and treatment of malaria.