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

NCT03993093 — Completed, 257 participants, Singh, Ranjan Kumar, M.D.

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AIDS Defining Opportunistic Infections in Naive HIV Cases

RegistryNCT03993093, acronym ADC
StatusCompleted
Study typeObservational
Enrollment257 (Actual)
SponsorSingh, Ranjan Kumar, M.D. (Indiv)
ConditionsHIV Infections, Tuberculosis, Candidiasis, Esophageal, Cryptococcosis, Leishmaniasis, Toxoplasmosis
InterventionsCD4 cell count (Other)
Datesstart 2019-06-01, primary completion 2020-02-28, completion 2020-03-15, first posted 2019-06-20, last updated 2020-03-19
Locations1 site in India

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-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
HIV with OIsOther: CD4 cell countTreatment naive HIV patients with OIs
  • CD4 cell count (Other): CD4 cell count from treatment naive HIV patients

+Outcome measures

Primary outcomes

  • 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 outcomes

  • 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.

+Eligibility

Sex: All, ages: 5 Years to any

Inclusion Criteria:

• HAART naïve HIV patient

Exclusion Criteria:

* Patients died during screening
* Transferred in HIV patients

+Locations (1)

FacilityCityCountryStatus
ART centre, Sadar HospitalKhagaria, BiharIndia

+Investigators

My Notes