An observational study in HIV Infections, sponsored by ViiV Healthcare. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2019-03-11.
Sponsored by ViiV Healthcare (part of GlaxoSmithKline) · Observational
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Among 265 studies in HIV Infections by GlaxoSmithKline — 14 open to participants now, 26 under way, 8 of them phase 3. HIV Infections · GlaxoSmithKline.
Among the 265 studies in HIV Infections by GlaxoSmithKline, this one is the 2nd largest by enrollment of the 14 observational ones that give a count, is one of 8 that started in 2018, is one of 14 observational ones, and was the 186th registered.
4,736 studies on the registry are indexed under HIV Infections; 246 are open to participants now.
Browse HIV Infections studies →14 of the 265 studies in HIV Infections by GlaxoSmithKline are open now, in 12 countries. Recruiting first, the newest first:
ViiV Healthcare · Sites in United States
Ages 18–55 · Healthy volunteers
ViiV Healthcare · Sites in Romania, South Africa, Uganda
ViiV Healthcare · Sites in Netherlands
Ages 18–55 · Healthy volunteers
ViiV Healthcare · Sites in United States
Ages 18–55 · Healthy volunteers
ViiV Healthcare · Sites in South Africa
Ages up to 10 days · Healthy volunteers
By country, each count listing its studies:
Of the 159 HIV Infections studies recruiting now, 104 (65%) set no upper age limit and 42 (26%) stop at 75 or younger; 31 take children under 18; 60 take healthy volunteers.
This study: 21 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.
265 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 84 · Phase 2 53 · Phase 3 68 · Phase 4 18
First in 1994; this study’s year is marked. 8 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 1,184 is above the median of 200 across 781 observational studies indexed under HIV Infections.
Median enrollment 84 across the 209 interventional studies, 328 across the 14 observational. Of the 230 that completed or were terminated, 95 (41%) have results posted.
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This study is registered under ViiV Healthcare, one of the names counted as GlaxoSmithKline. Under that name alone:
ViiV Healthcare is the lead sponsor of 266 studies on the registry; 17 are open to participants now.
Of its 71 completed or terminated interventional studies of FDA-regulated products, 53 (75%) have results posted.
5 of the studies in HIV Infections by GlaxoSmithKline that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07053384ViiV HealthcareA Study to Investigate the Use of VH3810109 With or Without Fostemsavir (FTR) to Reduce the Size and Activity of the Viral Reservoir in People Living With HIV | 2027-01-22 |
| NCT07934719ViiV HealthcareMass Balance and Absolute Bioavailability of [14C]-VH4011499 | 2027-02-18 |
| NCT06786520ViiV HealthcareA Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Cabotegravir Ultra Long-acting (CAB ULA) Following Switch From Cabotegravir Long-acting (CAB LA) in Healthy Adults | 2027-03-08 |
| NCT07525544ViiV HealthcareA Study to Investigate the Safety and PK of VH4770359 in Healthy Participants | 2027-05-05 |
| NCT07202546ViiV HealthcareA Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study) | 2027-10-28 |
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Among the 265 studies in HIV Infections by GlaxoSmithKline, from their registry updates:
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This study is designed to identify the burden associated with HIV and its treatment, and assess their health-related quality of life (HRQoL) by measuring key HRQoL domains, including satisfaction with treatment and care, and internalised stigma (ISAT). The study will also explore data for various important subpopulations such as subjects who are virally suppressed; who we anticipate will be the majority of study subjects. The study design is an observational, cross sectional study employing subjects' own mobile phone devices for data entry.
PLHIV will be recruited advertising in digital media. The study plan is to collect a complete set of data from 3000 PLHIV during a 90-180 day period in the US.
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.
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.
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.
Subjects living with HIV will be recruited via digital advertising. These subjects will participate in completing various PRO instruments and targeted questions.
Other: Functional Assessment of HIV Infection · Other: Patient Satisfaction Questionnaire · Other: Symptom Distress Module · Other: Patient Health Questionnaire · Other: Internalized Stigma of AIDS Tool · Other: Medication adherence visual analogue scale
Functional Assessment of HIV Infection will be used to assess HRQoL of subjects. This will include 47 items.
Patient Satisfaction Questionnaire will be used to assess burden and HRQoL in subjects. This will include 18 items.
Symptom Distress Module will be used to assess burden and HRQoL in subjects. This will include 20 items.
Patient Health Questionnaire will be used to assess burden and HRQoL in subjects. This will include 2 items.
Internalized Stigma of AIDS Tool will be used to assess burden and HRQoL in subjects. This will include 10 items.
Medication adherence visual analogue scale will be used to assess burden and HRQoL in subjects. This will include 1 item.
Percentage of virally suppressed PLHIV reporting different HRQoL scores
Evaluation of HRQoL will be conducted using scores achieved by Functional Assessment of HIV Infection (FAHI). QoL assessment will include physical well-being, social well-being, emotional well-being, functional and global well-being, and cognitive functioning
Time frame: Up to 1 Week
Percentage of virally suppressed PLHIV reporting different satisfaction with care scores
Evaluation of burden will include stigma, stigma, depression, and work productivity. The descriptive analysis will be assessed using Patient Satisfaction Questionnaire (PSQ)-18, Patient Health Questionnaire (PHQ)-2, and ISAT scores
Time frame: Up to 1 Week
Percent difference in HRQoL scores among subject subgroups
Subject subgroups are defined in terms of the following socio-demographic, clinical, and biomedical factors: a. Age: older versus. younger (i.e., \< 50 years old and over 50 years old) b. Gender (men / women / transgender) c. Race / ethnicity d. Sexual orientation (straight / gay / bisexual) e. Level of income f. Type of Insurance g. Apple (iPhone operating system) versus Android users h. Treatment regimen (e.g., number of pills per day, frequency of medication, single treatment regimen (STR) versus multiple treatment regimen (MTR) i. Diagnosis time / stage at which diagnosis was received (i.e. prompt vs. late diagnosis, time since diagnosis) j. Absence or presence (and number) of comorbidities k. Severity of symptoms (as assessed by the Symptom Distress Module patient reported outcome (PRO) instrument) l. Achievement of viral suppression.
Time frame: Up to 1 Week
Percentage of subjects reporting different HRQoL scores and relationship with satisfaction with care
Statistical correlation of reported QoL scores (FAHI) and satisfaction with care scores (PHQ-18) will be analyzed.
Time frame: Up to 1 Week
Percentage of subjects reporting diffferent HRQoL and medication adherence
Statistical correlation between QoL scores (FAHI) and adherence scores (adherence VAS) will be analyzed.
Time frame: Up to 1 Week
Ran from Jan 2018 to primary completion in Jul 2018, 5 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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