Prevalence of HIV +ve Cases With AIDS Defining Opportunistic Infections Among ART Naive Patients Attending ART Centre (ADC)
Singh, Ranjan Kumar, M.D.
Information provided by (Responsible Party)
Ranjan Kumar Singh, Singh, Ranjan Kumar, M.D.
First received: June 17, 2019
Last updated: March 18, 2020
Last Verified: March 2020
History of Changes
HIV patients are likely to suffer from opportunistic infections, in absence of highly active retroviral therapy. This happens due to lack of awareness of HIV status among patients or unresponsive to anti retroviral drugs. This study is for the prevalence of AIDS defining OIs among treatment naive HIV patients.
Other : CD4 cell count
Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||AIDS Defining Opportunistic Infections in Naive HIV Cases|
Further study details as provided by Ranjan Kumar Singh, Singh, Ranjan Kumar, M.D.:
Primary Outcome Measures
Prevalence of AIDS defining OIs
[ Time Frame: Six months ]
Calculate number of total HIV patients with or without opportunistic infections (n). Again calculate no of HIV patients with opportunistic infections (n1). Then calculate prevalence of HIV +ve patients with opportunistic infections by applying formula n1/n x100.
- Compare CD4 cell in cases of HIV with OIs with CD4 cell of HIV patients without OIs
[ Time Frame: Six months ]
Find out CD4 cell counts (cells /μL) of HIV patients with CD4 cell counts (cells/μL) of HIV patients without OIs. By calculating mean/SD of CD4 cells in both groups, comparison by chi square test would be done.
|Study Start Date:||June 1, 2019|
|Study Completion Date:||March 15, 2020|
|Primary Completion Date:||February 28, 2020 (Final data collection date for primary outcome measure)|
HIV with OIs
Treatment naive HIV patients with OIs
CD4 cell count
CD4 cell count from treatment naive HIV patients
Oppotunistic infections (OIs) happen in persons with weakened immune system. HIV patients,
who remain untreated due to lack of knowledge of existing HIV infections, often get OIs. HIV
patients with AIDS defining OIs fall into stage 3 of HIV illness. Prevalence of OIs in
resource poor settings are tuberculosis (pulmonary and extra pulmonary), toxoplasmosis,
cryptococcosis, and oesophageal candidiasis. There are a few data to show AIDS defining OIs
in treatment naïve HIV patients. Incidence of OIs among HIV patients in United States, and
Canada between 2000 to 2019 was 9%. Leading OIs were peumocystis Jiroveci, oesophageal
candidiasis and disseminated MAC or M. kansassi.
Minimal diagnoses at poor settings can be made by observation of symptoms, use of microscope, imaging and diagnostic therapy.
|Ages Eligible for Study:||5 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
Study PopulationAntiretroviral treatment naive HIV patients
• HAART naïve HIV patient
- Patients died during screening
- Transferred in HIV patients
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT03993093
Locations Show More
|ART centre, Sadar Hospital|
|Khagaria, Bihar, India, 851204|
Sponsors and CollaboratorsSingh, Ranjan Kumar, M.D.
|Principal Investigator:||Ranjan K Singh, M.D.||Singh, Ranjan Kumar|
|Responsible Party:||Ranjan Kumar Singh, Physician, cum nodal officer, ART centre Khagaria, Singh, Ranjan Kumar, M.D.|
|ClinicalTrials.gov Identifier:||NCT03993093 History of Changes|
|Other Study ID Numbers:||SinghRK1|
|Study First Received:||June 17, 2019|
|Last Updated:||March 18, 2020|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Keywords provided by Ranjan Kumar Singh, Singh, Ranjan Kumar, M.D.:HIV
CD4+ T cells
AIDS defining condition
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on June 02, 2020
This information is provided by ClinicalTrials.gov.