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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

shimaa sleem zyan, MD contact

01099959824

Sahyfadl@yahoo.com

Egypt1 site, 1 recruiting
  • Shimaa

    Asyut

    shimaa sl zyan, MD

    Recruiting

Other trials in Egypt

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.

  1. 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.

  1. First posted18 Apr 2022
  2. Study start1 Jan 2015
  3. Primary completion30 Dec 2021
  4. Study completionNov 2023 (estimated)

Resources

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)
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

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.

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