NCT05332808

Brief 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. 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 12, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 18, 2022

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

April 18, 2022

Status Verified

April 1, 2022

Enrollment Period

7 years

First QC Date

April 12, 2022

Last Update Submit

April 12, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • completion of questionnaire

    1 day

Interventions

collecting data about treatment and quality of life

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

HIV patients at upper Egypt hospitals

You may qualify if:

  • any HIV patient

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shimaa

Asyut, Egypt

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Central Study Contacts

shimaa sleem zyan, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 12, 2022

First Posted

April 18, 2022

Study Start

January 1, 2015

Primary Completion

December 30, 2021

Study Completion

November 1, 2023

Last Updated

April 18, 2022

Record last verified: 2022-04

Locations