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

HIV Infections Clinical Trial

— ADC  

Official title:

AIDS Defining Opportunistic Infections in Naive HIV Cases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03993093
• Other study ID #: SinghRK1
• Status: Completed
• Start date: June 1, 2019
• Est. completion date: March 15, 2020

Study information

• Verified date: March 2020
• Source: Singh, Ranjan Kumar, M.D.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 257
• Est. completion date: March 15, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years and older

Eligibility

Inclusion Criteria:

• HAART naïve HIV patient

Exclusion Criteria:

• Patients died during screening

• Transferred in HIV patients

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Esophageal
• Communicable Diseases
• Cryptococcosis
• HIV Infections
• Infection
• Leishmaniasis
• Opportunistic Infections
• Toxoplasmosis
• Tuberculosis

Intervention

Other:
• CD4 cell count
CD4 cell count from treatment naive HIV patients

Locations

Country	Name	City	State
India	ART centre, Sadar Hospital	Khagaria	Bihar

Sponsors (1)

Lead Sponsor	Collaborator
Singh, Ranjan Kumar, M.D.

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of AIDS defining OIs	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.	Six months
Secondary	Compare CD4 cell in cases of HIV with OIs with CD4 cell of HIV patients without OIs	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.	Six months