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Clinical Trials/NCT03993093
NCT03993093CompletedNot Applicable

AIDS Defining Opportunistic Infections in Naive HIV Cases

Singh, Ranjan Kumar, M.D.1 site in 1 country257 target enrollmentStarted: June 1, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
257
Locations
1
Primary Endpoint
Prevalence of AIDS defining OIs

Study Overview

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
5 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • HAART naïve HIV patient

Exclusion Criteria

  • Patients died during screening
  • Transferred in HIV patients

Outcomes

Primary Outcomes

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

  • Compare CD4 cell in cases of HIV with OIs with CD4 cell of HIV patients without OIs(Six months)

Investigators

Sponsor
Singh, Ranjan Kumar, M.D.
Sponsor Class
Indiv
Responsible Party
Principal Investigator
Principal Investigator

Ranjan Kumar Singh

Physician, cum nodal officer, ART centre Khagaria

Singh, Ranjan Kumar, M.D.

Study Sites (1)

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