An observational study in HIV/AIDS, sponsored by Michael Hoelscher. Active, not recruiting at 1 site in Tanzania. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-28.
Sponsored by Michael Hoelscher · Observational
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Among 48 studies in Acquired Immunodeficiency Syndrome with a site in Tanzania — 3 open to participants now, 4 under way, none of them phase 3. Acquired Immunodeficiency Syndrome · Tanzania.
Among the 48 studies in Acquired Immunodeficiency Syndrome with a site in Tanzania, this one is one of 2 that started in 2017, is one of 8 observational ones, and was the 29th registered.
3,037 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 307 are open to participants now.
Browse Acquired Immunodeficiency Syndrome studies →3 of the 48 studies in Acquired Immunodeficiency Syndrome with a site in Tanzania are open now. Recruiting first, the newest first:
Médecins du Monde · Sites in Tanzania, Armenia, Georgia
Ages 18+ · Healthy volunteers
RTI International · Sites in Tanzania
Ages 18+ · Women only
Duke University · Sites in Tanzania
Ages 18+
A study can be open while its sites in Tanzania have not opened yet or have stopped. Only those recruiting at a site in Tanzania →
Of the 198 Acquired Immunodeficiency Syndrome studies recruiting now, 118 (60%) set no upper age limit and 67 (34%) stop at 75 or younger; 43 take children under 18; 68 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
48 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 10 · Phase 3 12 · Phase 4 2
First in 2003; this study’s year is marked. 2 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 500 is above the median of 289 across 504 observational studies indexed under Acquired Immunodeficiency Syndrome.
Median enrollment 515 across the 40 interventional studies, 1,525 across the 8 observational. Of the 39 that completed or were terminated, 3 (8%) have results posted.
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1 of 48 have an industry lead sponsor. The 10 most frequent:
Michael Hoelscher is the lead sponsor of 19 studies on the registry; 4 are open to participants now.
Michael Hoelscher has 1 study filed under Acquired Immunodeficiency Syndrome — fewer than ten, so there is no comparison to draw.
1 of the studies in Acquired Immunodeficiency Syndrome with a site in Tanzania that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06395129Médecins du MondeLow Dead-space Injecting Equipment Distribution Program for People Who Inject Drugs in Low- and Middle-income Countries | 2027-11 |
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Among the 48 studies in Acquired Immunodeficiency Syndrome with a site in Tanzania, from their registry updates:
This tab as a report to print or save as PDF → With an account.
In natural HIV disease, a small fraction (1-2%) of infected individuals develops exceptionally high titres of HIV-1 neutralizing serum activity. Antibodies isolated from these individuals have been shown to be highly active against a broad range of different HIV strains and are therefore called broadly neutralizing antibodies (bNAbs). These antibodies are in fact able to prevent (S)HIV infection in animal models and therefore of great interest for the development of an HIV vaccine. Information of neutralizing antibodies in patients from Africa is still scarce and would be of great value in the development of adapted HIV vaccine strategies in these regions. This study aims to investigate African HIV-infected individuals, who have developed neutralizing antibodies using highly specialized laboratory methodologies.
Adult HIV-infected, preferentially ART-naïve patients within the Mbeya region. The prevalence of elite neutralizers is expected to be 1-2% from the overall population. The study therefore targets to recruit 500 subjects in order to identify at least 5 elite neutralizers, which will be subjected to further in depth antibody characterization.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Broadly HIV-1 neutralizing antibodies (bNAb)
identify HIV-infected patients which exhibit exceptional HIV-1 neutralizing activity (so called elite neutralizer) and to perform in those patients in depth characterization including: * Detailed analysis of anti-HIV antibody response using single B cell analyis * Isolation of broadly neutralizing anti-HIV antibodies * Testing of in vitro neutralizing activity and binding properties of newly identified bNAbs * Analysis of the antiviral activity and in vivo characteristics of broadly neutralizing antibodies using a HIV-1-infected humanized mouse model
Time frame: December 31, 2018
To characterize HIV subtypes in elite neutralizer and optionally in non-neutralizer
Time frame: December 31, 2018
To characterize demographic and HIV status related factors associated with elite neutralizers and non-neutralizers
Time frame: December 31, 2018
To optionally investigate the proportion of patients with transmitted drug mutations (genotypic drug resistance)
Time frame: December 31, 2018
Started Oct 2017 (actual). Primary completion is estimated for May 2024, 79 months after the start.
Of 165 non-industry observational studies under Acquired Immunodeficiency Syndrome, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 83. This study's planned 79 months is above that.
Counting every sponsor, half of 177 studies reached it within 44 months; a quarter within 19 and three quarters within 79.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome →
Michael Hoelscher