Acquired Immunodeficiency Syndrome Clinical Trial
Official title:
Implementation Protocol for Rapid Diagnostic Tests for Opportunistic Infections in Reference Centers in Mexico City
In Mexico City, the main cause of mortality among people living with HIV (PLHIV) continues to be opportunistic infections (OIs). Early detection of OIs allows their timely treatment and improves their prognosis. The use of rapid diagnostic tests (RDT) based on antigens of the most frequent causative agents of OIs allows adequate screening of these patients and facilitates decision making at the point of care. Unfortunately, these studies are not widely available in the different PLHIV care centers in the CDMX. We will conduct an open-label, non-inferiority uncontrolled clinical trial to investigate the diagnostic performance of urinary lipoarabinomannan, urinary Histoplasma antigen and serum Cryptococcus antigen in patients presenting for care with advanced HIV in CDMX, supported by rapid cluster of differentiation 4 (CD4) testing with lateral flow technology. Four referral hospitals will participate over 12 months. All patients with diagnosed HIV disease and suspected advanced disease presenting for care at participating centers will be included in the study. An inventory of approximately 1000 RDT will be obtained and distributed among the participating sites. A study coordinator will be hired and will visit each site once a week to collect the study variables and follow up on the included patients. The primary outcome of the study will be the percentage of patients with advanced disease who present with diagnoses made by RDT compared to historical controls of patients diagnosed with OI in 2022 at participating centers by conventional methods. Secondary outcomes will be time to initiation of antiretroviral therapy (ART), time to initiation of OI treatment, and 30-day mortality after HIV diagnosis.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01968551 -
Phase 3 Open-Label Study to Evaluate Switching From Optimized Stable Antiretroviral Regimens Containing Darunavir to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed Dose Combination (FDC) Plus Darunavir (DRV) in Treatment Experienced HIV-1 Positive Adults
|
Phase 3 | |
| Completed |
NCT02929069 -
A Unified Intervention for Young Gay and Bisexual Men's Minority Stress, Mental Health, and HIV Risk
|
N/A | |
| Recruiting |
NCT02392884 -
HIV Medication Adherence in Underserved Populations
|
N/A | |
| Completed |
NCT02264509 -
Peripheral Arterial Insufficiency Associated With HIV/AIDS
|
N/A | |
| Completed |
NCT02583464 -
Bioequivalence Study of Two Formulations With the Association of Tenofovir 300 mg and Emtricitabine 200 mg.
|
Phase 1 | |
| Completed |
NCT01440569 -
Safety and Efficacy of Cobicistat-boosted Darunavir in HIV Infected Adults
|
Phase 3 | |
| Completed |
NCT00551330 -
Vicriviroc in HIV(R5/X4)-Treatment Experienced Subjects (Study P05057AM5)(COMPLETED)
|
Phase 2 | |
| Completed |
NCT00381212 -
A Pilot Study to Investigate the Safety and Immunologic Activity AGS-004 an Autologous HIV Immunotherapeutic Agent.
|
Phase 1/Phase 2 | |
| Completed |
NCT00097006 -
Retrovirus Epidemiology Donor Study-II (REDS-II)
|
N/A | |
| Completed |
NCT00001409 -
Genetically Modified Lymphocytes to Treat HIV-Infected Identical Twins - Study Modifications
|
Phase 1 | |
| Completed |
NCT00000590 -
Anti-HIV Immunoglobulin (HIVIG) in Prevention of Maternal-Fetal HIV Transmission (Pediatric ACTG Protocol 185)
|
Phase 3 | |
| Completed |
NCT00000587 -
Erythropoietin for Anemia Due to Zidovudine in Human Immunodeficiency Virus Infection
|
Phase 2 | |
| Completed |
NCT00005273 -
Pulmonary Complications of HIV Infection Study (PACS)
|
N/A | |
| Completed |
NCT00005303 -
Effectiveness of AIDS Antibody Screening
|
N/A | |
| Completed |
NCT00005301 -
Transfusion Safety Study (TSS)
|
N/A | |
| Completed |
NCT00001650 -
Use of Bromodeoxyuridine to Study White Blood Cell Replication and Survival in HIV-Infected Patients
|
N/A | |
| Withdrawn |
NCT00243568 -
Vicriviroc, a CCR5 Inhibitor, Added to an Optimized Antiretroviral Therapy for Previously Treated HIV (VICTOR-E2) (Study P04285
|
Phase 3 | |
| Recruiting |
NCT05031819 -
Managing Hypertension Among People Living With HIV
|
N/A | |
| Completed |
NCT00394004 -
Decision-Making of Hispanics and African-Americans With HIV/AIDS Participating in Clinical Trials
|
N/A | |
| Completed |
NCT01967940 -
Efficacy of Tenofovir Alafenamide Versus Placebo Added to a Failing Regimen Followed by Treatment With Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Plus Atazanavir in HIV-1 Positive, Antiretroviral Treatment-Experienced Adults
|
Phase 3 |