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Prevalence of HIV +ve Cases With AIDS Defining Opportunistic Infections Among ART Naive Patients Attending ART Centre (ADC)
| Condition or disease | Intervention/treatment |
|---|---|
| HIV Infections Tuberculosis Candidiasis, Esophageal Cryptococcosis Leishmaniasis Toxoplasmosis | Other: CD4 cell count |
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 Type : | Observational |
| Actual Enrollment : | 257 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | AIDS Defining Opportunistic Infections in Naive HIV Cases |
| Actual Study Start Date : | June 1, 2019 |
| Actual Primary Completion Date : | February 28, 2020 |
| Actual Study Completion Date : | March 15, 2020 |
| Group/Cohort | Intervention/treatment |
|---|---|
|
HIV with OIs
Treatment naive HIV patients with OIs
|
Other: CD4 cell count
CD4 cell count from treatment naive HIV patients
|
- 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.
- 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.
| Ages Eligible for Study: | 5 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
• HAART naïve HIV patient
Exclusion Criteria:
- Patients died during screening
- Transferred in HIV patients
| India | |
| ART centre, Sadar Hospital | |
| Khagaria, Bihar, India, 851204 | |
| Principal Investigator: | Ranjan K Singh, M.D. | Singh, Ranjan Kumar |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | June 17, 2019 | ||||
| First Posted Date | June 20, 2019 | ||||
| Last Update Posted Date | March 19, 2020 | ||||
| Actual Study Start Date | June 1, 2019 | ||||
| Actual Primary Completion Date | February 28, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
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.
|
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures |
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.
|
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| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Prevalence of HIV +ve Cases With AIDS Defining Opportunistic Infections Among ART Naive Patients Attending ART Centre | ||||
| Official Title | AIDS Defining Opportunistic Infections in Naive HIV Cases | ||||
| 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. |
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| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Antiretroviral treatment naive HIV patients | ||||
| Condition |
|
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| Intervention | Other: CD4 cell count
CD4 cell count from treatment naive HIV patients
|
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| Study Groups/Cohorts | HIV with OIs
Treatment naive HIV patients with OIs
Intervention: Other: CD4 cell count
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
257 | ||||
| Original Estimated Enrollment |
200 | ||||
| Actual Study Completion Date | March 15, 2020 | ||||
| Actual Primary Completion Date | February 28, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria: • HAART naïve HIV patient Exclusion Criteria:
|
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| Sex/Gender |
|
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| Ages | 5 Years and older (Child, Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | India | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03993093 | ||||
| Other Study ID Numbers | SinghRK1 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | ||||
| Responsible Party | Ranjan Kumar Singh, Singh, Ranjan Kumar, M.D. | ||||
| Study Sponsor | Singh, Ranjan Kumar, M.D. | ||||
| Collaborators | Not Provided | ||||
| Investigators |
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| PRS Account | Singh, Ranjan Kumar, M.D. | ||||
| Verification Date | March 2020 | ||||
