Advanced HIV DiseaseNCT06852430
Factors Associated With Advanced HIV and Poor Nutrition Among People Living With HIV
An observational study of Advanced HIV Disease and Poor Nutriyion Among HIV Patients, run by Assiut University.
Trial summary
Aim of the work: 1. To determine the frequency of advanced HIV among PLWH in Assiut University Hospital. 2. To assess the nutritional patterns and frequency of poor nutrition among PLWH. 3. To evaluate factors associated with advanced HIV disease and poor nutrition among PLWH. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Advanced HIV Disease, Poor Nutriyion Among HIV Patients
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 22 Feb 2025to 1 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: People living with HIV disease who attend HIV Counselling Clinic and other departments at Assiut University Hospitals
Who may be able to join
- (1) Newly diagnosed people living with HIV (PLWH), (2) Patients previously diagnosed with HIV but non-compliant to treatment.
Who cannot join
- (1) PLWH compliant on ART, (2) PLWH who refuse to participate in the study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Factors Associated With Advanced HIV Disease and Poor Nutrition Among People Living With HIV: A Hospital-based Study
Aim of the work:
- To determine the frequency of advanced HIV among PLWH in Assiut University Hospital.
- To assess the nutritional patterns and frequency of poor nutrition among PLWH.
- To evaluate factors associated with advanced HIV disease and poor nutrition among PLWH.
Read the detailed description
Human immunodeficiency virus (HIV) is an RNA virus that attacks the human body's immune system, which results, in advanced cases, in expression of opportunistic infections (1). HIV infection represents a global public health burden (2, 3). In Egypt, in 2022, about 34,000 people (<0.1%) were positive for HIV (4). There is 25-30% annual increase of newly confirmed HIV cases in Egypt over the last 10 years (5).
The WHO defines advanced HIV disease as having CD4+ T-cell count <200 cell/mm3 or having an acquired immune deficiency syndrome (AIDS)-related infection (stage 3 or 4 of HIV infection) regardless of the CD4+ T-cell count (1).
The WHO reported, in 2022, that 630,000 people living with HIV (PLWH) died from AIDS-related diseases worldwide (which is 51% fewer than those in 2010) (2, 3, 6). In Egypt, the AIDS-related deaths increased from <100 PLWH in 1990 to <1000 PLWH in 2021 (5).
PLWH are usually malnourished due to opportunistic infections, poor food intake, changes in metabolic activity or chronic illnesses. Malnutrition leads to more impairment of the immune system and further disease progression (7).
According to 2023 Global Hunger index, Egypt is at a moderate level of food insecurity, ranking 57 out of 125 countries. 14.4% of the Egyptian population are food insecure (8).
In Egypt, there is lack of data about the frequency of advanced HIV disease and the nutritional status among PLWH and associated factors. Monitoring these factors could help in early treatment of HIV infection, prevention of further virus transmission and enhancement of the nutritional pattern among PLWH.
- Keywords
- Advanced HIV disease, AIDS, Acquired immunodeficiency syndrome, Nutrition in HIV disease, People living with HIV, PLWH
- 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.
| Study group | Role | What they receive |
|---|---|---|
| People living with Advanced HIV disease | Factors associated with advanced HIV disease | |
| People with Early HIV disease | Factors associated with early HIV disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Factors associated with advanced HIV disease and poor nutrition among people living with HIV disease.
To study factors associated with advanced HIV disease and poor nutrition among people living with HIV
Measured: Febraury 2025 to December 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start22 Feb 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Advanced HIV DiseaseStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salma Hussein Badry, Assiut University
- Investigators
- Haidi KaramAllah Ramadan, Assisstant professor, Study director, Assiut UniversityEhab Fawzy Abdou, Professor, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06852430
- Sponsor's protocol ID
- Advanced HIV, poor nutrition
- Status last verified
- Feb 2025
- First submitted
- 25 Feb 2025
- Last updated
- 28 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Boutros S, Skordis J. HIV/AIDS surveillance in Egypt: current status and future challenges. East Mediterr Health J. 2010 Mar;16(3):251-8.
PubMed 20795437Rezazadeh L, Ostadrahimi A, Tutunchi H, Naemi Kermanshahi M, Pourmoradian S. Nutrition interventions to address nutritional problems in HIV-positive patients: translating knowledge into practice. J Health Popul Nutr. 2023 Sep 8;42(1):94. doi: 10.1186/s41043-023-00440-z.
PubMed 37684634Ghazy RM, Al Awaidy S, Taha SHN. Trends of HIV indicators in Egypt from 1990 to 2021: time-series analysis and forecast toward UNAIDS 90-90-90 targets. BMC Public Health. 2023 Apr 1;23(1):625. doi: 10.1186/s12889-023-15490-5.
PubMed 37005670
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Associated With Advanced HIV Disease and Poor Nutrition Among People Living With HIV: A Hospital-based Study
- ClinicalTrials.gov ID
- NCT06852430
- Acronym / sponsor ID
- Advanced HIV, poor nutrition
- Keywords
- Advanced HIV disease, AIDS, Acquired immunodeficiency syndrome, Nutrition in HIV disease, People living with HIV, PLWH
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 22 Feb 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 28 Feb 2025 (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.
Aim of the work:
- To determine the frequency of advanced HIV among PLWH in Assiut University Hospital.
- To assess the nutritional patterns and frequency of poor nutrition among PLWH.
- To evaluate factors associated with advanced HIV disease and poor nutrition among PLWH.
Detailed description
Human immunodeficiency virus (HIV) is an RNA virus that attacks the human body's immune system, which results, in advanced cases, in expression of opportunistic infections (1). HIV infection represents a global public health burden (2, 3). In Egypt, in 2022, about 34,000 people (<0.1%) were positive for HIV (4). There is 25-30% annual increase of newly confirmed HIV cases in Egypt over the last 10 years (5).
The WHO defines advanced HIV disease as having CD4+ T-cell count <200 cell/mm3 or having an acquired immune deficiency syndrome (AIDS)-related infection (stage 3 or 4 of HIV infection) regardless of the CD4+ T-cell count (1).
The WHO reported, in 2022, that 630,000 people living with HIV (PLWH) died from AIDS-related diseases worldwide (which is 51% fewer than those in 2010) (2, 3, 6). In Egypt, the AIDS-related deaths increased from <100 PLWH in 1990 to <1000 PLWH in 2021 (5).
PLWH are usually malnourished due to opportunistic infections, poor food intake, changes in metabolic activity or chronic illnesses. Malnutrition leads to more impairment of the immune system and further disease progression (7).
According to 2023 Global Hunger index, Egypt is at a moderate level of food insecurity, ranking 57 out of 125 countries. 14.4% of the Egyptian population are food insecure (8).
In Egypt, there is lack of data about the frequency of advanced HIV disease and the nutritional status among PLWH and associated factors. Monitoring these factors could help in early treatment of HIV infection, prevention of further virus transmission and enhancement of the nutritional pattern among PLWH.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| People living with Advanced HIV disease | – | –Factors associated with advanced HIV disease |
| People with Early HIV disease | – | –Factors associated with early HIV disease |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- People living with HIV disease who attend HIV Counselling Clinic and other departments at Assiut University Hospitals
Key inclusion criteria (1 listed)
- (1) Newly diagnosed people living with HIV (PLWH), (2) Patients previously diagnosed with HIV but non-compliant to treatment.
Key exclusion criteria (1 listed)
- (1) PLWH compliant on ART, (2) PLWH who refuse to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Factors associated with advanced HIV disease and poor nutrition among people living with HIV disease.
Time frame: Febraury 2025 to December 2026
To study factors associated with advanced HIV disease and poor nutrition among people living with HIV
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Results publication: PubMed 20795437Boutros S, Skordis J. HIV/AIDS surveillance in Egypt: current status and future challenges. East Mediterr Health J. 2010 Mar;16(3):251-8.
- Results publication: PubMed 37684634Rezazadeh L, Ostadrahimi A, Tutunchi H, Naemi Kermanshahi M, Pourmoradian S. Nutrition interventions to address nutritional problems in HIV-positive patients: translating knowledge into practice. J Health Popul Nutr. 2023 Sep 8;42(1):94. doi: 10.1186/s41043-023-00440-z.
- Results publication: PubMed 37005670Ghazy RM, Al Awaidy S, Taha SHN. Trends of HIV indicators in Egypt from 1990 to 2021: time-series analysis and forecast toward UNAIDS 90-90-90 targets. BMC Public Health. 2023 Apr 1;23(1):625. doi: 10.1186/s12889-023-15490-5.
- WHO page about HIV, available at: https://www.who.int/news-room/fact-sheets/detail/hiv-aids?gad\_source=1\&gclid=Cj0KCQjwvb-zBhCmARIsAAfUI2sL\_nGP-V-oca55dZe0OroljeQgljfFO5\_s1FhbC6xFMxF\_mWBCrLink provided by the sponsor.
- WHO 2022, available at: https://www.who.int/news-room/fact-sheets/detail/hiv-aids?gad\_source=1\&gclid=Cj0KCQjwvb-zBhCmARIsAAfUI2sL\_nGP-V-oca55dZe0OroljeQgljfFO5\_s1FhbC6xFMxF\_mWBCrLink provided by the sponsor.
- 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.
Haidi KaramAllah Ramadan, Assisstant professor study director
Assiut University
Ehab Fawzy Abdou, Professor principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced HIV Disease and Poor Nutriyion Among HIV Patients, run by Assiut University.
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: opening soon, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Salma Hussein Badry, Resident doctor (+201123254745, Salma.16266321@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Factors associated with advanced HIV disease and poor nutrition among people living with HIV disease. (time frame: Febraury 2025 to December 2026). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06852430, which also lists 3 linked publications.
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 28 Feb 2025.