Highly Active Antiretroviral Therapy (HAART)-Related Nausea and VomitingPhase 2NCT00642499
Dronabinol Versus Placebo in Treatment and Prevention of Highly Active Anti-Retroviral Therapy (HAART)-Related Nausea and Vomiting
A Phase 2 study testing Dronabinol in people with Highly Active Antiretroviral Therapy (HAART)-Related Nausea and Vomiting and HIV Infections, run by Solvay Pharmaceuticals at 36 sites in United States.
Trial summary
The primary purpose of this study is to determine if dronabinol is effective in preventing or treating nausea caused by HAART (highly active anti-retroviral therapy) in HIV and AIDS patients Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Highly Active Antiretroviral Therapy (HAART)-Related Nausea and Vomiting, HIV Infections
- What is being tested?
- Dronabinol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- 36 sitesUnited States
- Study dates
- Aug 2003to Apr 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adherence to prior or current HAART was or is being compromised, or HAART was discontinued/interrupted due to nausea/vomiting; or beginning HAART or switching from a regimen at the time of screening for this study that did not produce significant nausea and/or vomiting to a regimen with zidovudine or a protease inhibitor (with or without low dose ritonavir).
Who cannot join
- Subjects with recent (within 30 days of randomization) or current opportunistic infection or neoplasm characteristic of AIDS (Category C of the CDC Classification System for HIV-1 infection, 1993 Revised Version).
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
United States36 sites
Site 921
Albany, New York
Site 907
Altamonte Springs, Florida
Site 911
Bakersfield, California
Site 905
Boise, Idaho
Site 934
Boston, Massachusetts
Site 914
Chicago, Illinois
Site 910
Cincinnati, Ohio
Site 925
Dallas, Texas
Site 908
Decatur, Georgia
Site 917
Fort Worth, Texas
Site 919
Fresno, California
Site 906
Houston, Texas
Site 942
Houston, Texas
Site 924
Los Angeles, California
Site 932
Los Angeles, California
Site 928
Louisville, Kentucky
Site 955
Louisville, Kentucky
Site 948
Miami, Florida
Site 951
Miami, Florida
Site 953
Miami, Florida
Site 959
Miami, Florida
Site 958
New Orleans, Louisiana
Site 954
North Palm Beach, Florida
Site 926
Palm Springs, California
Site 946
Pasadena, California
Site 957
Pensacola, Florida
Site 941
Philadelphia, Pennsylvania
Site 923
Port Saint Lucie, Florida
Site 929
Sarasota, Florida
Site 956
Somers Point, New Jersey
Site 915
Springfield, Missouri
Site 909
Tacoma, Washington
Site 952
Tallahassee, Florida
Site 931
Tampa, Florida
Site 913
Tarzana, California
Site 927
Vancouver, Washington
About this study
Official title: A Double-Blind, Randomized, Parallel-Group, Pilot Study of Oral Dronabinol Versus Placebo in the Treatment or Prevention of Highly Active Antiretroviral Therapy (HAART)-Related Nausea and Vomiting
The primary purpose of this study is to determine if dronabinol is effective in preventing or treating nausea caused by HAART (highly active anti-retroviral therapy) in HIV and AIDS patients
- Being tested
- Dronabinol, Placebo
- Keywords
- HIV, AIDS, nausea, vomiting, HAART, Treatment Experienced, HIV Infections
- Medical subject headings
- Vomiting, HIV Infections, Acquired Immunodeficiency Syndrome, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DronabinolDrug
2.5 mg to 40 mg
PlaceboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Dronabinol |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The absence of nausea as indicated by a visual analog scale (VAS) score < 5 mm
Measured: 2 weeks
Secondary outcomes (4)
Number of episodes vomiting/retching
Measured: 2 weeks
Duration of nausea, vomiting/retching
Measured: 2 weeks
Intensity of nausea by VAS
Measured: 2 weeks
Appetite stimulation by VAS
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2008 (estimated)
- Study startAug 2003
- Primary completionApr 2005
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Highly Active Antiretroviral Therapy (HAART)-Related Nausea and VomitingStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solvay Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Global Clinical Director Solvay, Study director, Solvay Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00642499
- Sponsor's protocol ID
- S175.2.101
- Status last verified
- Mar 2008
- First submitted
- 21 Mar 2008
- Last updated
- 2 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Parallel-Group, Pilot Study of Oral Dronabinol Versus Placebo in the Treatment or Prevention of Highly Active Antiretroviral Therapy (HAART)-Related Nausea and Vomiting
- ClinicalTrials.gov ID
- NCT00642499
- Acronym / sponsor ID
- S175.2.101
- Keywords
- HIV, AIDS, nausea, vomiting, HAART, Treatment Experienced, HIV Infections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Solvay PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2003
- Primary completion
- Apr 2005 (actual)
- Study completion
- Apr 2005 (actual)
- First posted
- 25 Mar 2008 (estimated)
- 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.
The primary purpose of this study is to determine if dronabinol is effective in preventing or treating nausea caused by HAART (highly active anti-retroviral therapy) in HIV and AIDS patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Dronabinol |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adherence to prior or current HAART was or is being compromised, or HAART was discontinued/interrupted due to nausea/vomiting; or beginning HAART or switching from a regimen at the time of screening for this study that did not produce significant nausea and/or vomiting to a regimen with zidovudine or a protease inhibitor (with or without low dose ritonavir).
Key exclusion criteria (1 listed)
- Subjects with recent (within 30 days of randomization) or current opportunistic infection or neoplasm characteristic of AIDS (Category C of the CDC Classification System for HIV-1 infection, 1993 Revised Version).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dronabinol2.5 mg to 40 mg | Drug | 1 |
| Placeboplacebo | Drug | 2 |
Primary outcome
The absence of nausea as indicated by a visual analog scale (VAS) score < 5 mm
Time frame: 2 weeks
4 secondary outcomes
Number of episodes vomiting/retching
Time frame: 2 weeks
Duration of nausea, vomiting/retching
Time frame: 2 weeks
Intensity of nausea by VAS
Time frame: 2 weeks
Appetite stimulation by VAS
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2008.
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. This study is not recruiting at the moment.
Global Clinical Director Solvay study director
Solvay Pharmaceuticals
36 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dronabinol in people with Highly Active Antiretroviral Therapy (HAART)-Related Nausea and Vomiting and HIV Infections, run by Solvay Pharmaceuticals at 36 sites in United States.
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: finished, as of the sponsor's last update on 2 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The absence of nausea as indicated by a visual analog scale (VAS) score < 5 mm (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Apr 2008.