HivNCT05332808
Treatment State and Quality of Life in HIV- Infected Patients in Upper Egypt
An observational study of Hiv, run by Assiut University at 1 site in Egypt.
Trial summary
HIV stands for Human Immunodeficiency Virus, a pathogen that works by attacking the human immune system. It belongs to a class of viruses called retroviruses and more specifically, a subgroup called lentiviruses, or viruses that cause disease slowly. In 2020, there were about 37.7 million people living with HIV. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hiv
- What is being tested?
- questionnare
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2015to Nov 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: HIV patients at upper Egypt hospitals
Who may be able to join
- any HIV patient
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
HIV stands for Human Immunodeficiency Virus, a pathogen that works by attacking the human immune system. It belongs to a class of viruses called retroviruses and more specifically, a subgroup called lentiviruses, or viruses that cause disease slowly.
In 2020, there were about 37.7 million people living with HIV. Only 84% of all people living with HIV knew their HIV status in 2020, with 680 000 people died from AIDS-related illnesses in 2020 .
Read more
HIV cannot replicate on its own, so in order to make new copies of itself, it must infect cells of the human immune system, called CD4 cells. . CD4 cells are white blood cells that play a central role in responding to infections in the body. Over time, CD4 cells are killed by HIV and the body's ability to recognise and fight some types of infection begins to decline If HIV is not controlled by treatment, the loss of CD4 cells leads to the development of serious illnesses, or 'opportunistic infections'. In people with normal CD4 cell levels, these infections would be recognised and cleared by the immune system.
Experiencing a collection of these infections is the most advanced stage of HIV, which is when a person is also said to have AIDS (Acquired Immune Deficiency Syndrome). Effective testing and treatment of HIV means that the large majority of people living with HIV do not reach this stage.
Stages of HIV :
An initial acute infection; (ii) a long asymptomatic period; and (iii) a final increase in viral load with a simultaneous collapse in healthy CD4+ T cell count during which AIDS appears During the acute infection period (2-10 weeks) there is a sharp drop in the concentration of circulating CD4+ T cells, and a large spike in the level of circulating free virus. Clinically the patient suffers from infectious mononucleosis-like systemic illness with fever, diarrhoea, often a transient meningo-encephalitis and even lung pneumocystosis .After this period, the level of circulating CD4+ T cells returns to ''near-normal'' levels, and the viral load drops dramatically. In this asymptomatic or latent period, the patient does not exhibit any major symptoms of disease, even though HIV is continuously infecting new cells and actively replicating. Normally this latent period ranges in duration from 7 to 10 years, Following this asymptomatic period, the viral load rises rapidly with a simultaneous drop in CD4+ T cell count. This last stage is called AIDS, and is defined by situations where CD4+ T cell counts are below 200 cells/mm3 or when certain opportunistic infections are experience Treatment for HIV Antiretroviral medicines are used to treat HIV. They work by stopping the virus replicating in the body, allowing the immune system to repair itself and preventing further damage. These come in the form of tablets, which need to be taken every day.
HIV is able to develop resistance to a single HIV medicine very easily, but taking a combination of different medicines makes this much less likely. Most people with HIV take a combination of medicines. It's vital these are taken every day as recommended by your doctor. The goal of HIV treatment is to have an undetectable viral load. This means the level of HIV virus in your body is low enough to not be detected by a test.
Quality of life of HIV infected patients:
Quality of life has been considered synonymous with health status, functional status, psychological wellbeing, happiness with life, satisfaction of needs, and assessment of one's own life . Assessment of quality of life has become an important outcome measure in the management of HIV/AIDS and reflects improvement or otherwise of the health experience and satisfaction with care among patients living with HIV/AIDS
- Conditions
- Hiv
- Being tested
- questionnare
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnareOther
collecting data about treatment and quality of life
What is being measured
The primary outcome is the main question the study is designed to answer.
completion of questionnaire
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2022
- Study start1 Jan 2015
- Primary completion30 Dec 2021
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HivStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shimaa Saleem Zayan, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05332808
- Sponsor's protocol ID
- HIV patients characteristics
- Status last verified
- Apr 2022
- First submitted
- 12 Apr 2022
- Last updated
- 18 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment State and Quality of Life in HIV- Infected Patients in Upper Egypt
- ClinicalTrials.gov ID
- NCT05332808
- Acronym / sponsor ID
- HIV patients characteristics
- Conditions
- Hiv
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- Nov 2023 (estimated)
- First posted
- 18 Apr 2022 (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 stands for Human Immunodeficiency Virus, a pathogen that works by attacking the human immune system. It belongs to a class of viruses called retroviruses and more specifically, a subgroup called lentiviruses, or viruses that cause disease slowly.
In 2020, there were about 37.7 million people living with HIV. Only 84% of all people living with HIV knew their HIV status in 2020, with 680 000 people died from AIDS-related illnesses in 2020 .
HIV cannot replicate on its own, so in order to make new copies of itself, it must infect cells of the human immune system, called CD4 cells. . CD4 cells are white blood cells that play a central role in responding to infections in the body. Over time, CD4 cells are killed by HIV and the body's ability to recognise and fight some types of infection begins to decline If HIV is not controlled by treatment, the loss of CD4 cells leads to the development of serious illnesses, or 'opportunistic infections'. In people with normal CD4 cell levels, these infections would be recognised and cleared by the immune system.
Experiencing a collection of these infections is the most advanced stage of HIV, which is when a person is also said to have AIDS (Acquired Immune Deficiency Syndrome). Effective testing and treatment of HIV means that the large majority of people living with HIV do not reach this stage.
Stages of HIV :
An initial acute infection; (ii) a long asymptomatic period; and (iii) a final increase in viral load with a simultaneous collapse in healthy CD4+ T cell count during which AIDS appears During the acute infection period (2-10 weeks) there is a sharp drop in the concentration of circulating CD4+ T cells, and a large spike in the level of circulating free virus. Clinically the patient suffers from infectious mononucleosis-like systemic illness with fever, diarrhoea, often a transient meningo-encephalitis and even lung pneumocystosis .After this period, the level of circulating CD4+ T cells returns to ''near-normal'' levels, and the viral load drops dramatically. In this asymptomatic or latent period, the patient does not exhibit any major symptoms of disease, even though HIV is continuously infecting new cells and actively replicating. Normally this latent period ranges in duration from 7 to 10 years, Following this asymptomatic period, the viral load rises rapidly with a simultaneous drop in CD4+ T cell count. This last stage is called AIDS, and is defined by situations where CD4+ T cell counts are below 200 cells/mm3 or when certain opportunistic infections are experience Treatment for HIV Antiretroviral medicines are used to treat HIV. They work by stopping the virus replicating in the body, allowing the immune system to repair itself and preventing further damage. These come in the form of tablets, which need to be taken every day.
HIV is able to develop resistance to a single HIV medicine very easily, but taking a combination of different medicines makes this much less likely. Most people with HIV take a combination of medicines. It's vital these are taken every day as recommended by your doctor. The goal of HIV treatment is to have an undetectable viral load. This means the level of HIV virus in your body is low enough to not be detected by a test.
Quality of life of HIV infected patients:
Quality of life has been considered synonymous with health status, functional status, psychological wellbeing, happiness with life, satisfaction of needs, and assessment of one's own life . Assessment of quality of life has become an important outcome measure in the management of HIV/AIDS and reflects improvement or otherwise of the health experience and satisfaction with care among patients living with HIV/AIDS
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- HIV patients at upper Egypt hospitals
Key inclusion criteria (1 listed)
- any HIV patient
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| questionnarecollecting data about treatment and quality of life | Other | – |
Primary outcome
completion of questionnaire
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2022.
- Individual participant dataSharing planned: Undecided
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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.
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, run by Assiut University at 1 site in Egypt.
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 1 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: status not confirmed, as of the sponsor's last update on 18 Apr 2022. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact shimaa sleem zyan, MD (01099959824, Sahyfadl@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
completion of questionnaire (time frame: 1 day). 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 18 Apr 2022.