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A Phase I/II Study to Evaluate Single Agent and Combination Therapy With Megestrol Acetate and Dronabinol for the Treatment of HIV-Wasting Syndrome Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about A Phase I/II Study to Evaluate Single Agent and Combination Therapy With Megestrol Acetate and Dronabinol for the Treatment of HIV-Wasting Syndrome conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Phase I/II Study to Evaluate Single Agent and Combination Therapy With Megestrol Acetate and Dronabinol for the Treatment of HIV-Wasting Syndrome Clinical research trials and A Phase I/II Study to Evaluate Single Agent and Combination Therapy With Megestrol Acetate and Dronabinol for the Treatment of HIV-Wasting Syndrome medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like 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 I/II Study to Evaluate Single Agent and Combination Therapy With Megestrol Acetate and Dronabinol for the Treatment of HIV-Wasting Syndrome Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a A Phase I/II Study to Evaluate Single Agent and Combination Therapy With Megestrol Acetate and Dronabinol for the Treatment of HIV-Wasting Syndrome clinical trial. Test subjects typically obtain the finest healthcare available for their A Phase I/II Study to Evaluate Single Agent and Combination Therapy With Megestrol Acetate and Dronabinol for the Treatment of HIV-Wasting Syndrome condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > 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 I/II Study to Evaluate Single Agent and Combination Therapy With Megestrol Acetate and Dronabinol for the Treatment of HIV-Wasting Syndrome
A Phase I/II Study to Evaluate Single Agent and Combination Therapy With Megestrol Acetate and Dronabinol for the Treatment of HIV-Wasting Syndrome
For Condition: Cachexia,HIV Infections,HIV Wasting Syndrome
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Roxane Laboratories,Bristol-Myers Squibb
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Open Label, Pharmacokinetics Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria 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. - 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. Exclusion Criteria 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. - 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).
Total Enrollment: 56
Location and Contact Information:
Overall Study Official:
GalettoG, Study Chair,
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, 972109951
United States
Univ of Maryland at Baltimore / Veterans Adm
Baltimore, Maryland, 21201
United States
Tulane Univ Med School
New Orleans, Louisiana, 701122699
United States
Univ of Rhode Island / College of Pharmacy
Providence, Rhode Island, 02908
United States
Washington Univ
St. Louis, Missouri, 63110
United States
Univ of Kansas School of Medicine
Wichita, Kansas, 67214
United States
Denver Public Health Dept
Denver, Colorado, 802044507
United States
SUNY / Health Sciences Ctr at Brooklyn
Brooklyn, New York, 11203
United States
Univ of Illinois
Chicago, Illinois, 60612
United States
Additional Information:
Study ID Numbers: DATRI 004;
Study Start Date:
Record last reviewed: January 1994
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000737
Other Hiv Wasting Syndrome Studies:
1. Phase III Randomized Double-Blind Study Comparing Megestrol Acetate at 800 mg/day, and Placebo in AIDS Patients With Anorexia and Cachexia
2. A Phase I/II Study to Evaluate Single Agent and Combination Therapy With Megestrol Acetate and Dronabinol for the Treatment of HIV-Wasting Syndrome
3. A Study of Different Doses of Megestrol Acetate in Patients with AIDS Who Have Anorexia and Malnutrition
4. Cyproheptadine and Megestrol in Preventing Weight Loss in Children With Cachexia Caused By Cancer or Cancer Treatment
5. Comparison of Megestrol and/or Omega-3 Fatty Acid-Enriched Nutritional Supplement in Treating Patients With Cancer-Related Weight Loss and Lack of Appetite
Related Studies:
Other HIV Wasting Syndrome Clinical Trials
Other Rhode Island Clinical Trials
Other Providence Clinical Trials
A Phase I/II Study to Evaluate Single Agent and Combination Therapy With Megestrol Acetate and Dronabinol for the Treatment of HIV-Wasting Syndrome
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