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NCT ID: NCT02396394 Completed - HIV Clinical Trials

Improving ART Retention and Adherence in Uganda: The WiseMama Study

WiseMama
Start date: May 2015
Phase: N/A
Study type: Interventional

WiseMama is designed to improve our understanding of interventions that are feasible and effective in helping HIV-positive pregnant and postpartum women to maintain high adherence to antiretroviral medications. The study will involve: a) assessing the feasibility and acceptability of the use of an innovative pill container equipped with real-time electronic data monitoring capacity by HIV positive pregnant and postpartum women in Uganda; b) generating preliminary effectiveness data of a 2-step feedback intervention on retention in care, antiretroviral therapy adherence, and clinical outcomes (CD4 and HIV viral load (VL)); c) exploring patient and provider perspectives on barriers and facilitators to retention in care and adherence to antiretroviral therapy in our study population.

NCT ID: NCT02383108 Completed - HIV Infection Clinical Trials

Strategy for Maintenance of HIV Suppression With Once Daily Integrate Inhibitor+Darunavir/Ritonavir in Children

SMILE
Start date: June 2016
Phase: Phase 2/Phase 3
Study type: Interventional

A two-arm, Phase 2/3 multicentre, open-label, randomised study evaluating safety and antiviral effect of current standard antiretroviral therapy compared to once daily integrase inhibitor administered with darunavir/ritonavir (DRV/r) in HIV-1 infected, virologically suppressed paediatric participants.

NCT ID: NCT02381470 Completed - Clinical trials for Pulmonary Tuberculosis

Trial of Faropenem and Cefadroxil (in Combination With Amoxicillin/Clavulanic Acid and Standard TB Drugs) in Patients With Pulmonary Tuberculosis: Measurement of Early Bactericidal Activity and Effects on Novel Biomarkers

Start date: February 11, 2019
Phase: Phase 2
Study type: Interventional

This trial aims to determine whether the early bactericidal activity of rifampicin given with faropenem or cefadroxil (each given with amoxicillin/clavulanic acid) is greater than the activity of rifampicin alone in patients with pulmonary TB. The trial will also investigate potential new biomarkers of sterilising activity.

NCT ID: NCT02376582 Completed - HIV/AIDS Clinical Trials

Safety and Immunogenicity Study of a DNA Vaccine Combined With Protein Vaccine Against HIV/AIDS

EV06
Start date: September 2014
Phase: Phase 1
Study type: Interventional

The primary objective of the proposed phase I trial is to evaluate the safety and tolerability of DNA-HIV-PT123 and AIDSVAX®B/E combination regimen. Though both DNA-HIV-PT123 and AIDSVAX®B/E and the combination of the two vaccines have been evaluated in humans and have shown to be safe and well tolerated, this is the first time the combination regimen is being evaluated in HIV-1 uninfected African populations with and without S. mansoni. The secondary objective of the trial is to evaluate the effect of S. mansoni infection on the immunogenicity of the combination of DNA-HIV-PT123 and AIDSVAX® B/E vaccine regimen. Successful vaccination against most viruses requires efficient Th1 response. There is evidence that helminth infections skew the host immune system of human and animals to T-helper type 2 (Th2) and induce immunosuppression. Therefore, there is a potential that helminth infected populations may not generate the desired immune responses to vaccines designed to drive Th1-type and cytotoxic T-cell responses. Furthermore, the influence of helminth infections on the development of protective antibody responses remains unclear. Limited data in animal models suggests that worm infections reduced efficacy of vaccines. The proposed vaccine trial will generate safety, tolerability and immunogenicity data of a vaccination regimen with simultaneous administration of a candidate HIV DNA vaccine (DNA-HIV-PT123) and a gp120 protein vaccine (AIDSVAX®B/E). This will be the first HIV vaccine trial to prospectively evaluate the impact of the S. mansoni infection on safety and immune responses to HIV vaccines.

NCT ID: NCT02376400 Completed - Healthy Clinical Trials

A Study to Assess the Safety and Immunogenicity of Heterologous Prime-Boost Ebola Vaccine Regimens in Healthy Participants

Start date: April 2015
Phase: Phase 1
Study type: Interventional

The purpose of this study is to test the safety and immunogenicity of MVA-BN-Filo and Ad26.ZEBOV administered as heterologous prime-boost vaccine regimens in healthy adult participants.

NCT ID: NCT02372812 Completed - Pain Clinical Trials

Analgesic Effects Of Dexamethasone; Its Use To Reduce Post Operative Pain Scores

DOPP
Start date: July 2014
Phase: Phase 2
Study type: Interventional

A randomised controlled clinical trial to assess the effect of intraoperative dexamethasone on the 24 hour post operative pain scores of adult patients in Mulago hospital undergoing mastectomies, laparotomies and thyroidectomies. The adverse effects of dexamethasone at this dose were also assessed for.

NCT ID: NCT02358616 Completed - HIV Prevention Clinical Trials

An Exploratory Study of Potential Sources of Efficacy Dilution in the VOICE Trial (MTN-003)

Start date: December 2012
Phase:
Study type: Observational

This study is primarily exploratory and is designed to both identify factors that may have affected participant adherence to study product in VOICE, and describe how sexual behaviors, such as anal sex, may have had an effect on product efficacy. As such there is no specific hypothesis that is being tested.

NCT ID: NCT02354404 Completed - Clinical trials for Hemorrhagic Fever, Ebola

Clinical Trial of Ebola Vaccines cAd3-EBO, cAd3-EBOZ and MVA-EbolaZ in Healthy Adults in Uganda

Start date: January 27, 2015
Phase: Phase 1
Study type: Interventional

Phase Ib study in 90 healthy adults,18 years to 65 years of age, to evaluate the safety, tolerability and immunogenicity of the VRC-EBOADC069-00-VP (cAd3-EBO) and VRC-EBOADC076-00-VP (cAd3-EBOZ) investigational Ebola vaccines in Part 1 and boosting with the VRC-EBOMVA079-00-VP (MVA-EbolaZ) investigational Ebola vaccine in Part 2. Part 1: Randomizations to cAd3-EBO or cAd3-EBOZ at two different dose levels within Group 1 will include at least 60 volunteers who have never received an investigational Ebola vaccine. Randomizations to cAd3-EBO at two different dose levels within Group 2 may include up to 30 eligible participants who previously participated in the RV247 vaccine clinical trial and received the investigational VRC-EBODNA023-00-VP (Ebola DNA WT) vaccine. Part 2: Participants in Part 1 may receive a booster vaccination with the MVA-EbolaZ vaccine at the same dose level.

NCT ID: NCT02346487 Completed - HIV Clinical Trials

Prospective Study of Lopinavir Based ART for HIV Infected childreN Globally (LIVING Study)

LIVING
Start date: September 2015
Phase: Phase 3
Study type: Interventional

The study will be carried out to provide supportive clinical data on the feasibility, efficacy, safety, and PK of LPV based therapies in routine treatment setting and will be based on the existing LPV/r pellets which already represent a clear advantage in comparison with the liquid formulation.

NCT ID: NCT02344290 Completed - HIV Infections Clinical Trials

Evaluating the Use of Pitavastatin to Reduce the Risk of Cardiovascular Disease in HIV-Infected Adults

REPRIEVE
Start date: March 26, 2015
Phase: Phase 3
Study type: Interventional

People infected with HIV are at risk for cardiovascular disease (CVD). This study will evaluate the use of pitavastatin to reduce the risk of CVD in adults infected with HIV who are on antiretroviral therapy (ART). The REPRIEVE trial consists of two parallel identical protocols: - REPRIEVE (A5332) is funded by the NHLBI, with additional infrastructure support provided by the NIAID, and is conducted in U.S and select international sites (approximately 120 sites in 11 countries). - REPRIEVE (EU5332) is co-sponsored by NEAT ID and MGH, and is conducted at 13 sites in Spain.