Clinical Trials

MainTitle

Prevalence of HIV +ve Cases With AIDS Defining Opportunistic Infections Among ART Naive Patients Attending ART Centre (ADC)

This study has been completed
Sponsor
Singh, Ranjan Kumar, M.D.


Information provided by (Responsible Party)
Ranjan Kumar Singh, Singh, Ranjan Kumar, M.D.

ClinicalTrials.gov Identifier
NCT03993093

First received: June 17, 2019
Last updated: March 18, 2020
Last Verified: March 2020
History of Changes
Purpose

Purpose

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.

Condition Intervention
HIV Infections
Tuberculosis
Candidiasis, Esophageal
Cryptococcosis
Leishmaniasis
Toxoplasmosis

Other : CD4 cell count

Study Type: Observational
Study Design: 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.
Secondary Outcome Measures:
  • 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.

Enrollment: 257
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)

Arms Assigned Interventions
HIV with OIs
Treatment naive HIV patients with OIs
Other: CD4 cell count

CD4 cell count from treatment naive HIV patients

Detailed Description:

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.

Eligibility

Eligibility

Ages Eligible for Study: 5 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  
Sampling Method: Non-Probability Sample  

Study Population

Antiretroviral treatment naive HIV patients

Criteria

Inclusion Criteria:
• HAART naïve HIV patient

Exclusion Criteria:

    • Patients died during screening
    • Transferred in HIV patients

contacts and locations

Contacts and Locations

Choosing 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

India
ART centre, Sadar Hospital
Khagaria, Bihar, India, 851204

Sponsors and Collaborators

Singh, Ranjan Kumar, M.D.

Investigators

Principal Investigator: Ranjan K Singh, M.D. Singh, Ranjan Kumar
More Information

More Information


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
Opportunistic infection
CD4+ T cells
AIDS defining condition

Additional relevant MeSH terms:
Infection
Communicable Diseases
Tuberculosis
Candidiasis
Opportunistic Infections
Cryptococcosis
Leishmaniasis
Toxoplasmosis

ClinicalTrials.gov processed this data on June 02, 2020
This information is provided by ClinicalTrials.gov.