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

NCT03993093 | Completed

• 1 other identifier: SinghRK1
• Study Type: observational
• Target: 257
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections; Tuberculosis; Candidiasis, Esophageal; Cryptococcosis; Leishmaniasis; Toxoplasmosis

Keywords

HIV; Opportunistic infection; CD4+ T cells; AIDS defining condition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Compare CD4 cell in cases of HIV with OIs with CD4 cell of HIV patients without OIs

  Six months

Study Arms (1)

HIV with OIs

Treatment naive HIV patients with OIs

Other: CD4 cell count

Interventions

CD4 cell count OTHER

CD4 cell count from treatment naive HIV patients

HIV with OIs

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Antiretroviral treatment naive HIV patients

You may qualify if:

• HAART naïve HIV patient

You may not qualify if:

• Patients died during screening
• Transferred in HIV patients

Sponsors & Collaborators

• Singh, Ranjan Kumar, M.D.: lead

Study Sites (1)

ART centre, Sadar Hospital

Khagaria, Bihar, 851204, India

Location

MeSH Terms

Conditions

HIV Infections; Tuberculosis; Candidiasis; Cryptococcosis; Leishmaniasis; Toxoplasmosis; Opportunistic Infections

Interventions

CD4 Lymphocyte Count

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Mycoses; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Skin Diseases, Parasitic; Vector Borne Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Coccidiosis

Intervention Hierarchy (Ancestors)

Lymphocyte Count; Leukocyte Count; Blood Cell Count; Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Ranjan K Singh, M.D.

  Singh, Ranjan Kumar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDIV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician, cum nodal officer, ART centre Khagaria

Study Record Dates

• First Submitted: June 17, 2019
• First Posted: June 20, 2019
• Study Start: June 1, 2019
• Primary Completion: February 28, 2020
• Study Completion: March 15, 2020
• Last Updated: March 19, 2020

Record last verified: 2020-03

Locations

IN (1)