A Phase 2 interventional study of Zaleplon in HIV/AIDS and Clinical Depression, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-10-16.
Sponsored by University of Pennsylvania · Phase 2, Interventional, and Treatment
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Among 31 studies in Acquired Immunodeficiency Syndrome by University of Pennsylvania — 1 open to participants now, 4 under way, none of them phase 3. Acquired Immunodeficiency Syndrome · University of Pennsylvania.
Among the 31 studies in Acquired Immunodeficiency Syndrome by University of Pennsylvania, this one is the 26th largest by enrollment of the 30 interventional ones that give a count, is the only one that started in 2014, is one of 2 in phase 2, and was the 16th registered.
3,037 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 307 are open to participants now.
Browse Acquired Immunodeficiency Syndrome studies →1 of the 31 studies in Acquired Immunodeficiency Syndrome by University of Pennsylvania is open now, in 1 country. Recruiting first, the newest first:
University of Pennsylvania · Sites in United States
Ages 18+
By country, each count listing its studies:
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 to 65 Years · 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.
31 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 4 · Phase 2 4 · Phase 3 3 · Phase 4 1
First in 2004; this study’s year is marked. 1 started in 2014.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 20 is below the median of 96 across 2,252 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Median enrollment 243 across the 30 interventional studies, 80 across the 1 observational. Of the 26 that completed or were terminated, 12 (46%) have results posted.
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University of Pennsylvania is the lead sponsor of 1,668 studies on the registry; 234 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 110 (70%) have results posted.
1 of the studies in Acquired Immunodeficiency Syndrome by University of Pennsylvania that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03617198University of PennsylvaniaCD4 CAR+ ZFN-modified T Cells in HIV Therapy | 2026-12 |
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Among the 31 studies in Acquired Immunodeficiency Syndrome by University of Pennsylvania, from their registry updates:
This tab as a report to print or save as PDF → With an account.
In HIV positive patients with sleep onset insomnia and receiving pharmacologic treatment for comorbid depression, the proposed study aims to evaluate the impact of zaleplon on sleep measures determined by insomnia severity index (ISI) and Epworth sleepiness scale (ESS).
An estimated >50% of HIV positive individuals report insomnia. Insomnia and other sleep disturbances negatively impact outcomes in this population by contributing to metabolic dysfunction, reducing quality of life, and impairing psychosocial functioning. Additionally, in HIV depressed populations, insomnia may hinder remission from clinical depression. To date, there have been no pharmacotherapeutic studies treating insomnia in this population, emphasizing the need to determine whether known hypnotic medications work as effectively in HIV positive patients, including those with comorbid depression. Non-benzodiazepine hypnotics represent an attractive pharmacotherapy for treatment of insomnia in a depressed population, as there are reduced side effects and abuse potential compared to classical benzodiazepines. Consequently, an open-label study evaluating zaleplon for insomnia in HIV positive patients with comorbid depression warrants further study.
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.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
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.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Open-label zaleplon 5-10mg daily
Drug: Zaleplon
non-benzodiazepine hypnotic agent
Insomnia Severity Index (ISI)
The Insomnia Severity Index is a validated sleep scale that measures clinical insomnia severity. The total score ranges from 0-28 where higher values indicate increased severity of insomnia.
Time frame: Measure at 6 weeks
Epworth Sleepiness Scale (ESS)
The Epworth Sleepiness Scale (ESS) is a validated sleep scale that quantifies daytime sleepiness across eight domains. The total score ranges from 0-24 where higher values indicate greater daytime sleepiness.
Time frame: Measure at 6 weeks
Quick Inventory of Depressive Symptomatology (QIDS)
The Quick Inventory of Depressive Symptomatology (QIDS) is a validated mood scale that quantifies depression symptoms. The total score ranges from 0-48, where higher values indicate greater depressive symptoms.
Time frame: Measure at 6 weeks
| Milestone | Zaleplon |
|---|---|
| Started | 20 |
| Completed | 16 |
| Not completed | 4 |
| Withdrew: Lost to follow-up | 4 |
The Insomnia Severity Index is a validated sleep scale that measures clinical insomnia severity. The total score ranges from 0-28 where higher values indicate increased severity of insomnia.
| score on a scale | Zaleplon |
|---|---|
| Insomnia Severity Index (ISI) | 11 ± 4.5 |
The Epworth Sleepiness Scale (ESS) is a validated sleep scale that quantifies daytime sleepiness across eight domains. The total score ranges from 0-24 where higher values indicate greater daytime sleepiness.
| score on a scale | Zaleplon |
|---|---|
| Epworth Sleepiness Scale (ESS) | 6.5 ± 4.9 |
The Quick Inventory of Depressive Symptomatology (QIDS) is a validated mood scale that quantifies depression symptoms. The total score ranges from 0-48, where higher values indicate greater depressive symptoms.
| score on a scale | Zaleplon |
|---|---|
| Quick Inventory of Depressive Symptomatology (QIDS) | 8.7 ± 6.3 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Zaleplon | — | 0/20 (0%) | 0/20 (0%) |
| Age, Categorical(Participants) | Zaleplon |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 20 |
| >=65 years | 0 |
| Age, Continuous(years) | Zaleplon |
|---|---|
| Mean | 49 ± 9 |
| Sex: Female, Male(Participants) | Zaleplon |
|---|---|
| Female | 6 |
| Male | 14 |
| Race (NIH/OMB)(Participants) | Zaleplon |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 16 |
| White | 4 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Zaleplon |
|---|---|
| United States | 20 |
Plan to share: No
Ran from Apr 2014 to primary completion in Feb 2015, 10 months.
Results were first posted in Sep 2018, 3 years 7 months after primary completion.
Of 57 non-industry phase 2 interventional studies under Acquired Immunodeficiency Syndrome, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 65. This study's 10 months is below that.
Counting every sponsor, half of 86 studies reached it within 36 months; a quarter within 18 and three quarters within 71.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Zaleplon
Acquired Immunodeficiency Syndrome →