CachexiaPhase 1NCT00000737
A Phase I/II Study to Evaluate Single Agent and Combination Therapy With Megestrol Acetate and Dronabinol for the Treatment of HIV-Wasting Syndrome
A Phase 1 study testing Dronabinol and Megestrol acetate in people with Cachexia and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 9 sites in United States.
Trial summary
To obtain data on the safety of administering megestrol acetate and dronabinol as single agents or in combination to patients with human immunodeficiency virus (HIV)-wasting syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cachexia, HIV Infections, HIV Wasting Syndrome
- What is being tested?
- Dronabinol and Megestrol acetate
- How many people
- 56 participants
- Where
- 9 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Concurrent Medication:
- Allowed:
- Zidovudine (AZT), didanosine (ddI), and dideoxycytidine (ddC). If initiating new antiretroviral therapy, patient must have been on a stable dose for at least 4 weeks prior to study entry.
- Maintenance or suppressive therapy with any of the following, provided patient has been on a stable dose for at least 1 week prior to study entry:
- Ganciclovir or foscarnet for CMV retinitis.
- Fluconazole, amphotericin B, or flucytosine for cryptococcosis.
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- Amphotericin B for disseminated histoplasmosis.
- Pyrimethamine, sulfadiazine, dapsone, or clindamycin for toxoplasmosis.
- Amikacin, clarithromycin, clofazimine, ethambutol, ciprofloxacin, or rifampin for disseminated Mycobacterium avium complex.
- Isoniazid, rifampin, ethambutol, or pyrazinamide for M. tuberculosis.
- Any of the following provided patient is on a stable dose for at least 1 week prior to study entry:
- Trimethoprim-sulfamethoxazole, aerosolized pentamidine, or dapsone for Pneumocystis carinii prophylaxis.
- Clotrimazole troches, nystatin suspension, ketoconazole, or fluconazole for oral candidiasis.
- Oral acyclovir for mucocutaneous herpes simplex.
- Narcotic analgesics, tranquilizers, sedative-hypnotics, or anticholinergic agents provided patient is on a stable dose for at least 1 week prior to study entry.
- Patients must have:
- HIV infection.
- HIV-wasting syndrome and anorexia.
- Life expectancy of at least 4 months.
- Ability to tolerate oral therapy, feed themselves, and have access to as much food as they desire with no dietary restrictions.
- Prior Medication:
- Allowed:
- Prior zidovudine (AZT), didanosine (ddI), and dideoxycytidine (ddC).
- Prior maintenance or suppressive therapy for certain opportunistic infections, as follows:
- Ganciclovir or foscarnet for CMV retinitis.
- Fluconazole, amphotericin B, or flucytosine for cryptococcosis.
- Amphotericin B for disseminated histoplasmosis.
- Pyrimethamine, sulfadiazine, dapsone, or clindamycin for toxoplasmosis.
- Amikacin, clarithromycin, clofazimine, ethambutol, ciprofloxacin, or rifampin for disseminated Mycobacterium avium complex.
- Isoniazid, rifampin, ethambutol, or pyrazinamide for M. tuberculosis.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Major, acute opportunistic infections.
- Active neoplasms other than Kaposi's sarcoma or localized skin carcinoma.
- Diabetes, congestive heart failure, clinical ascites, or uncontrolled hypertension.
- Persistent grade 3/4 diarrhea.
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- Impaired oral intake, such as occurs with Candida esophagitis or severe mouth ulcers.
- Clinically significant cardiac arrhythmias.
- Requirement for anticonvulsants for seizure disorder.
- Concurrent Medication:
- Excluded:
- Marijuana use.
- Anabolic steroids.
- Anticonvulsants for seizure disorders.
- Alcohol or barbiturates.
- Patients with the following prior conditions are excluded:
- Diagnosis of a major, acute opportunistic infection within 2 months prior to study entry.
- Hospitalization within 2 weeks prior to study entry.
- History of hypersensitivity reactions to megestrol acetate, dronabinol, or sesame oil (a component of the dronabinol capsules).
- History of thromboembolic events.
- History of psychiatric disorder other than depression.
- Prior Medication:
- Excluded:
- Prior dronabinol.
- Megestrol acetate within 2 months prior to study entry.
- Marijuana within 1 month prior to study entry.
- Anabolic steroids within 3 months prior to study entry.
- Current drug or alcohol abuse (patients with a history of occasional marijuana use are eligible provided they have abstained from its use for 1 month prior to study entry and agree to refrain from marijuana use for the study period).
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Univ of Maryland at Baltimore / Veterans Adm
Baltimore, Maryland, 21201
SUNY / Health Sciences Ctr at Brooklyn
Brooklyn, New York, 11203
Univ of Illinois
Chicago, Illinois, 60612
Denver Public Health Dept
Denver, Colorado, 802044507
Tulane Univ Med School
New Orleans, Louisiana, 701122699
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, 972109951
Univ of Rhode Island / College of Pharmacy
Providence, Rhode Island, 02908
Washington Univ
St Louis, Missouri, 63110
Univ of Kansas School of Medicine
Wichita, Kansas, 67214
About this study
To obtain data on the safety of administering megestrol acetate and dronabinol as single agents or in combination to patients with human immunodeficiency virus (HIV)-wasting syndrome. To obtain preliminary data on the efficacy of single agent and combination therapy with megestrol acetate and dronabinol with regard to weight gain, appetite increase and quality of life in this patient population. To obtain steady-state pharmacokinetics data when megestrol acetate and dronabinol are administered as single agents and in combination.
HIV-wasting syndrome, which is characterized by severely debilitating anorexia and weight loss, is of particular concern because it can exacerbate the primary illness and is associated with a poor prognosis. Attempts at maintaining body mass through the use of megestrol acetate and dronabinol, two anti-cachectic drugs, may prolong survival.
Read the detailed description
HIV-wasting syndrome, which is characterized by severely debilitating anorexia and weight loss, is of particular concern because it can exacerbate the primary illness and is associated with a poor prognosis. Attempts at maintaining body mass through the use of megestrol acetate and dronabinol, two anti-cachectic drugs, may prolong survival.
Fifty-six patients are randomized to one of four treatment arms, as follows: high-dose megestrol acetate alone; dronabinol alone; high-dose megestrol acetate combined with dronabinol; or low-dose megestrol acetate combined with dronabinol. Treatment continues for 12 weeks. Patients are evaluated for toxicity, preliminary evidence of response (e.g., weight gain), and steady-state pharmacokinetics of drug therapies.
- Conditions
- Cachexia, HIV Infections, HIV Wasting Syndrome
- Being tested
- Dronabinol, Megestrol acetate
- Keywords
- Weight Loss, Megestrol, Cachexia, Eating Disorders, Tetrahydrocannabinol, Appetite
- Medical subject headings
- Cachexia, HIV Infections, HIV Wasting Syndrome, Weight Loss, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DronabinolDrug
Megestrol acetateDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CachexiaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 56 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Roxane Laboratories, Bristol-Myers Squibb
- Investigators
- Galetto G, Study chairEgorin M, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000737
- Sponsor's protocol ID
- DATRI 004
- Status last verified
- Jan 1994
- First submitted
- 2 Nov 1999
- Last updated
- 25 Aug 2008
- Results posted
- No
Publications
Timpone JG, Wright DJ, Li N, Egorin MJ, Enama ME, Mayers J, Galetto G. The safety and pharmacokinetics of single-agent and combination therapy with megestrol acetate and dronabinol for the treatment of HIV wasting syndrome. The DATRI 004 Study Group. Division of AIDS Treatment Research Initiative. AIDS Res Hum Retroviruses. 1997 Mar 1;13(4):305-15. doi: 10.1089/aid.1997.13.305.
PubMed 9071430
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study to Evaluate Single Agent and Combination Therapy With Megestrol Acetate and Dronabinol for the Treatment of HIV-Wasting Syndrome
- ClinicalTrials.gov ID
- NCT00000737
- Acronym / sponsor ID
- DATRI 004
- Conditions
- Cachexia, HIV Infections, HIV Wasting Syndrome
- Keywords
- Weight Loss, Megestrol, Cachexia, Eating Disorders, Tetrahydrocannabinol, Appetite
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Roxane Laboratories, Bristol-Myers Squibb
- First posted
- 31 Aug 2001 (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.
To obtain data on the safety of administering megestrol acetate and dronabinol as single agents or in combination to patients with human immunodeficiency virus (HIV)-wasting syndrome. To obtain preliminary data on the efficacy of single agent and combination therapy with megestrol acetate and dronabinol with regard to weight gain, appetite increase and quality of life in this patient population. To obtain steady-state pharmacokinetics data when megestrol acetate and dronabinol are administered as single agents and in combination.
HIV-wasting syndrome, which is characterized by severely debilitating anorexia and weight loss, is of particular concern because it can exacerbate the primary illness and is associated with a poor prognosis. Attempts at maintaining body mass through the use of megestrol acetate and dronabinol, two anti-cachectic drugs, may prolong survival.
Detailed description
HIV-wasting syndrome, which is characterized by severely debilitating anorexia and weight loss, is of particular concern because it can exacerbate the primary illness and is associated with a poor prognosis. Attempts at maintaining body mass through the use of megestrol acetate and dronabinol, two anti-cachectic drugs, may prolong survival.
Fifty-six patients are randomized to one of four treatment arms, as follows: high-dose megestrol acetate alone; dronabinol alone; high-dose megestrol acetate combined with dronabinol; or low-dose megestrol acetate combined with dronabinol. Treatment continues for 12 weeks. Patients are evaluated for toxicity, preliminary evidence of response (e.g., weight gain), and steady-state pharmacokinetics of drug therapies.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- Zidovudine (AZT), didanosine (ddI), and dideoxycytidine (ddC). If initiating new antiretroviral therapy, patient must have been on a stable dose for at least 4 weeks prior to study entry.
- Maintenance or suppressive therapy with any of the following, provided patient has been on a stable dose for at least 1 week prior to study entry:
- Ganciclovir or foscarnet for CMV retinitis.
- Fluconazole, amphotericin B, or flucytosine for cryptococcosis.
- Amphotericin B for disseminated histoplasmosis.
Key exclusion criteria (28 listed)
- Major, acute opportunistic infections.
- Active neoplasms other than Kaposi's sarcoma or localized skin carcinoma.
- Diabetes, congestive heart failure, clinical ascites, or uncontrolled hypertension.
- Persistent grade 3/4 diarrhea.
- Impaired oral intake, such as occurs with Candida esophagitis or severe mouth ulcers.
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 |
|---|---|---|
| Dronabinol | Drug | – |
| Megestrol acetate | Drug | – |
Primary outcome
Not reported in the source record.
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 25 Aug 2008.
- Background: PubMed 9071430Timpone JG, Wright DJ, Li N, Egorin MJ, Enama ME, Mayers J, Galetto G. The safety and pharmacokinetics of single-agent and combination therapy with megestrol acetate and dronabinol for the treatment of HIV wasting syndrome. The DATRI 004 Study Group. Division of AIDS Treatment Research Initiative. AIDS Res Hum Retroviruses. 1997 Mar 1;13(4):305-15. doi: 10.1089/aid.1997.13.305.
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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. This study is not recruiting at the moment.
Galetto G study chair
Egorin M study chair
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dronabinol and Megestrol acetate in people with Cachexia and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 9 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 30 inclusion and 28 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 25 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000737, which also lists 1 linked publication.
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 25 Aug 2008.