Summary Of Studies

Name of StudyBrief DescriptionStatus
A5225 A Phase I/II dose finding, randomized controlled trial conducted in multiple sites comparing high dose fluconazole to current standard of care (Amphotericin B and Fluconazole. Doses of up to 2000mg of Fluconazole used. The study was conducted in phases which included dose escalation and validation of maximum tolerated dose to determine safety, tolerability, and therapeutic effects of high-dose fluconazole alone for the treatment of cryptococcal meningitis (CM) in HIV-infected participants.
A total of 192 participants enrolled.
Accrual closed
Enrolled 20 participants
A5263/AMC066A prospective, randomized, active-controlled multicentre clinical trial comparing clinical efficacy of Three Regimens of Chemotherapy with Compatible Antiretroviral Therapy for Treatment of Advanced AIDS-KS in Resource-Limited Settings for initial treatment of advanced stage AIDS-KS.

A total of 706 particpants will be enrolled.
Enrolling
A5264/AMC067
(REACT-KS)
A phase III, open-label, prospective, multicentre, randomized clinical trial for Evaluation of Antiretroviral Therapy Alone or with Delayed Chemotherapy versus Antiretroviral Therapy with Immediate Adjunctive Chemotherapy for initial Treatment of Limited Stage AIDS-related Kaposi’s sarcoma (AIDS-KS) in HIV-1 infected participants who are currently not receiving ART.

A total of 468 participants will be enrolled on the study.
Closed to accrual.
Enrolled 6 participant
A5274/REMEMBER (Reducing Early Mortality and Early Morbidity by Empiric TB Treatment Regimens)A phase IV randomized, open-label, multicenter clinical trial of participants from resource-limited settings (RLS) who present with advanced HIV disease and no probable or confirmed tuberculosis (TB) initiating antiretroviral treatment (ART). These participants will be randomized to one of two strategy arms: immediate, empiric TB treatment (public health approach) or local standard of care TB treatment (individualized approach).

A total of 836 participants will be enrolled.
Closed to accrual
Enrolled 13 participant
A5278/AMC Phamacology Substudies of A5263 and A5264 to investigate the potential for drug-drug interactions among agents used for the chemotherapy of KS and co-formulated EFV/TDF/FTC. Enrolling
A5279A randomized, open-label, phase III multicentre clinical trial of Ultra-Short-Course Rifapentine/Isoniazid for the Prevention of Active Tuberculosis in HIV-Infected Individuals with Latent Tuberculosis Infection The study will also assess safety and tolerability of the regimens, adherence to the treatments, and patterns of antibiotic resistance among Mycobacterium tuberculosis isolates in participants who fail on these prophylactic regimens.

A total of 3000 participants were be enrolled.
Closed to accrual.
Enrolled 131 Participants
A5282A Randomized, Phase II Trial to Compare an HPV Test-and-Treat Strategy to a Cytology-based Strategy for Prevention of CIN 2+ in HIV-infected Women

A total of 450 participants were be enrolled
Closed to accrual
Enrolled 55 participants

A total of 450 participants were be enrolled
A5288
(MULTI-OCTAVE)
Management Using the Latest Technologies in Resource-limited Settings to Optimize Combination Therapy After Viral Failure : an open-label phase IV, prospective interventional, multicentre strategy study in resource-limited settings (RLS) for HIV-infected participants with triple-class experience or resistance to [nucleoside reverse transcriptase inhibitors (NRTIs), non-NRTIs (NNRTIs), and protease inhibitors (PIs)] and who are failing their current regimen. The use of novel agents and contemporary management tools that include standard genotyping, plasma viral load (VL) monitoring will be evaluated. The screening genotype results and antiretroviral (ARV) history will be used to allocate potential participants to one of the four cohorts and for selection of ARV regimen for each potential participant.

A total of 500 participant were enrolled
Closed to accrual
Enrolled 18 participants
A5290 A Randomized, Phase 2b Study of a Double-Dose Lopinavir/Ritonavir-Based Antiretroviral Regimen with Rifampin-Based Tuberculosis Treatment versus a Standard-Dose Lopinavir/Ritonavir-Based Antiretroviral Regimen with Rifabutin-Based Tuberculosis Treatment with or without Raltegravir in HIV-1-Infected Persons Requiring Treatment for Active TB and HIV.

A total of 471 participants were enrolled
Closed to accrual
A5300/IMPAACT 2003
PHOENIx Feasibility Study
Study of MDR TB Cases and Their Household Contacts: Operational
Feasibility to Inform PHOENIx Trial Design
Closed to accrual
Enrolled 35 participants
A5302
BioBank for Surrogate Marker Research for TB (B-SMART) for use in future TB biomarker research.


Enrolling
A5338A phase II open-label, single arm, multicenter, open-Label, Non-Randomized Study of Pharmacokinetic Interactions Among Depot Medroxyprogesterone Acetate (DMPA), Rifampicin
(RIF), and Efavirenz (EFV) in Women Co-Infected with Human Immunodeficiency Virus (HIV) and Tuberculosis (TB).

A total of 46 evaluable participants were enrolled.
Closed to accrual
Enrolled 14 participants
A5349A randomized, open-label, controlled phase 3 clinical trial To evaluate the efficacy of Rifapentine-containing treatment shortening regimens for treatment of pulmonary tuberculosis Enrolling
START Strategic Timing of AntiRetroviral Treatment: A randomized controlled trial of HIV infected ART naïve patients to determine whether early initiation (CD4 count >500) is superior to deferred initiation (CD4 count <350). It is aimed at assessing the risks and determine the effectiveness of early ART in HIV-infected individuals with a CD4+ cell count > 500 cells/mm3.

A total of 4000 were enrolled
Closed to accrual
Enrolled 125 participants
DNDiThis is a multicentre, 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.
Closed to accrual
Enrolled 12 participants
SALIFA Phase 3b, Randomized, Open-label Clinical Study to Demonstrate Non-inferiority in Virologic Response Rates of HIV-1 RNA Suppression <400 Copies/mL of TDF/FTC/RPV Versus TDF/FTC/EFV in First-line Antiretroviral NNRTI-based Suppressed Patients Switching At Low HIV-1 RNA Into Fixed Dose CombinationsClosed to accrual
Enrolled 14 participants
STANDA Phase 3 Open-Label Partially Randomized Trial multicentre clinical trial to Evaluate the Efficacy, Safety and Tolerability of the Combination of Moxifloxacin plus PA-824 plus Pyrazinamide after 4 and 6 months of Treatment in Adult Subjects with Drug-Sensitive Smear-Positive Pulmonary Tuberculosis and after 6 months of Treatment in Adult Subjects with Multi-Drug Resistant, Smear-Positive Pulmonary TuberculosisAccrual paused
Enrolled 11 participants thus far
A5332/ REPRIEVERandomized Trial to Prevent Vascular Events in HIV: A prospective, double-blind, randomized, placebo-controlled, multicenter efficacy trial to study the efficacy of statins to reduce the risk of cardiovascular disease in HIV-infected patients.

A total of 6500 will be enrolled.
Enrolment pending
DNDi2/LIVING studyThis is an open-label, prospective, non-randomized, multi-centre, single arm phase IIIb study to evaluate effectiveness, safety, tolerance and acceptability when used in field/programmatic conditions in countries most affected by the HIV epidemic.Enrolment pending
Gilead: GS-US-380-1474 A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the GS-9883/Emtricitabine/Tenofovir Alafenamide (GS-9883/F/TAF) Fixed Dose Combination (FDC) in HIV-1 Infected Virologically Suppressed Adolescents and ChildrenEnrolment pending
GSK 201585 (ATLAS)A Phase III, randomized, multicenter, parallel-group, noninferiority, open-label study evaluating the efficacy, safety, and tolerability of switching to long-acting cabotegravir plus longacting rilpivirine from current INI- NNRTI-, or PI-based antiretroviral regimen in HIV-1-infected adults who are
virologically suppressed
Enrolment pending
GSK 201584 (FLAIR)A Phase III, Randomized, Multicenter, Parallel-group, Open-Label Study Evaluating the Efficacy, Safety, and Tolerability of Long-Acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch from an Integrase Inhibitor Single Tablet Regimen in HIV-1 Infected
Antiretroviral Therapy Naive Adult Participants
Enrolment pending
ODYSSEYA Randomised Trial of Dolutegravir (DTG)-based Antiretroviral Therapy vs. Standard of Care (SOC) in Children with HIV Infection Starting First-line or Switching to Second-line ARTEnrolment pending