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Completed

NCT Number: NCT03993093

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • HAART naïve HIV patient

Exclusion criteria

  • Patients died during screening
  • Transferred in HIV patients

Treatment and study plan

CD4 cell count

Other

CD4 cell count from treatment naive HIV patients

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Singh, Ranjan Kumar, M.D.

Indiv

Registry information

Official study title

AIDS Defining Opportunistic Infections in Naive HIV Cases

Acronym: ADC

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 20, 2019
Registry last updated
Mar 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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