HIV InfectionsADCNCT03993093
Prevalence of HIV +ve Cases With AIDS Defining Opportunistic Infections Among ART Naive Patients Attending ART Centre
An observational study of HIV Infections and Tuberculosis, run by Singh, Ranjan Kumar, M.D. at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- HIV Infections, Tuberculosis, Candidiasis, Esophageal
- What is being tested?
- CD4 cell count
- How many people
- 257 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jun 2019to 15 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Antiretroviral treatment naive HIV patients
Who may be able to join
- HAART naïve HIV patient
Who cannot join
- Patients died during screening
- Transferred in HIV patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: AIDS Defining Opportunistic Infections in Naive HIV Cases
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.
Read the 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.
- Conditions
- HIV Infections, Tuberculosis, Candidiasis, Esophageal, Cryptococcosis, Leishmaniasis, Toxoplasmosis
- Being tested
- CD4 cell count
- Keywords
- HIV, Opportunistic infection, CD4+ T cells, AIDS defining condition
- Medical subject headings
- HIV Infections, Tuberculosis, Candidiasis, Cryptococcosis, Leishmaniasis, Toxoplasmosis, Opportunistic Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD4 cell countOther
CD4 cell count from treatment naive HIV patients
| Study group | Role | What they receive |
|---|---|---|
| HIV with OIs | Treatment naive HIV patients with OIs Receives: Other: CD4 cell count |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Six months
Secondary outcomes (1)
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.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2019
- Study start1 Jun 2019
- Primary completion28 Feb 2020
- Study completion15 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 257 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singh, Ranjan Kumar, M.D.
- Responsible party
- Principal investigator, Ranjan Kumar Singh, Singh, Ranjan Kumar, M.D.
- Investigators
- Ranjan K Singh, M.D., Principal investigator, Singh, Ranjan Kumar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03993093
- Sponsor's protocol ID
- SinghRK1
- Acronym
- ADC
- Status last verified
- Mar 2020
- First submitted
- 17 Jun 2019
- Last updated
- 19 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AIDS Defining Opportunistic Infections in Naive HIV Cases
- ClinicalTrials.gov ID
- NCT03993093
- Acronym / sponsor ID
- ADC / SinghRK1
- Conditions
- HIV Infections, Tuberculosis, Candidiasis, Esophageal, Cryptococcosis, Leishmaniasis, Toxoplasmosis
- Keywords
- HIV, Opportunistic infection, CD4+ T cells, AIDS defining condition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 257 participants (actual)
- Lead sponsor
- Singh, Ranjan Kumar, M.D.
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 20 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIV with OIs | – | Other: CD4 cell countTreatment naive HIV patients with OIs |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Antiretroviral treatment naive HIV patients
Key inclusion criteria (1 listed)
- HAART naïve HIV patient
Key exclusion criteria (2 listed)
- Patients died during screening
- Transferred in HIV patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CD4 cell countCD4 cell count from treatment naive HIV patients | Other | HIV with OIs |
Primary outcome
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.
1 secondary outcome
Compare CD4 cell in cases of HIV with OIs with CD4 cell of HIV patients without OIs
Time frame: Six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2020.
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ranjan K Singh, M.D. principal investigator
Singh, Ranjan Kumar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and Tuberculosis, run by Singh, Ranjan Kumar, M.D. at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of AIDS defining OIs (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2020.