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

Completed

• Conditions: Candidiasis, Esophageal; Leishmaniasis; Cryptococcosis; Toxoplasmosis; HIV Infections; Tuberculosis
• Interventions: Other: CD4 cell count

• Registration Number: NCT03993093
• Lead Sponsor: Singh, Ranjan Kumar, M.D.

Brief Summary

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.

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.

Study Timeline

• Study Start: 2019-06-01
• Study First Submitted: 2019-06-17
• Study First Submitted QC: 2019-06-19
• Study First Posted: 2019-06-20
• Primary Completion: 2020-02-28
• Status Verified: 2020-03
• Study Completion: 2020-03-15
• Last Update Submitted: 2020-03-18
• Last Update Posted: 2020-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 257

Inclusion Criteria

• HAART naïve HIV patient

Exclusion Criteria

• Patients died during screening
• Transferred in HIV patients

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HIV with OIs	CD4 cell count	Treatment naive HIV patients with OIs

Primary Outcome Measures

Name	Time	Method
Prevalence of AIDS defining OIs	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

Name	Time	Method
Compare CD4 cell in cases of HIV with OIs with CD4 cell of HIV patients without OIs	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.

Trial Locations

Locations (1)

ART centre, Sadar Hospital; 🇮🇳 Khagaria, Bihar, India