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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Roxane Laboratories Bristol-Myers Squibb |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000737 |
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.
Condition | Intervention | Phase |
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Cachexia HIV Infections HIV Wasting Syndrome |
Drug: Dronabinol Drug: Megestrol acetate |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Pharmacokinetics Study |
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 |
Estimated Enrollment: | 56 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
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).
United States, Colorado | |
Denver Public Health Dept | |
Denver, Colorado, United States, 802044507 | |
United States, Illinois | |
Univ of Illinois | |
Chicago, Illinois, United States, 60612 | |
United States, Kansas | |
Univ of Kansas School of Medicine | |
Wichita, Kansas, United States, 67214 | |
United States, Louisiana | |
Tulane Univ Med School | |
New Orleans, Louisiana, United States, 701122699 | |
United States, Maryland | |
Univ of Maryland at Baltimore / Veterans Adm | |
Baltimore, Maryland, United States, 21201 | |
United States, Missouri | |
Washington Univ | |
St Louis, Missouri, United States, 63110 | |
United States, New York | |
SUNY / Health Sciences Ctr at Brooklyn | |
Brooklyn, New York, United States, 11203 | |
United States, Oregon | |
Portland Veterans Adm Med Ctr / Rsch & Education Grp | |
Portland, Oregon, United States, 972109951 | |
United States, Rhode Island | |
Univ of Rhode Island / College of Pharmacy | |
Providence, Rhode Island, United States, 02908 |
Study Chair: | Galetto G | |
Study Chair: | Egorin M |
Study ID Numbers: | DATRI 004 |
Study First Received: | November 2, 1999 |
Last Updated: | August 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00000737 |
Health Authority: | United States: Federal Government |
Weight Loss Megestrol Cachexia |
Eating Disorders Tetrahydrocannabinol Appetite |
Sexually Transmitted Diseases, Viral Metabolic Diseases HIV Wasting Syndrome Acquired Immunodeficiency Syndrome Cachexia Emaciation Megestrol Immunologic Deficiency Syndromes Tetrahydrocannabinol Body Weight Virus Diseases |
Signs and Symptoms HIV Infections Weight Loss Sexually Transmitted Diseases Body Weight Changes Nutrition Disorders Metabolic disorder Wasting Syndrome Retroviridae Infections Megestrol Acetate Eating Disorders |
Slow Virus Diseases Antineoplastic Agents Contraceptive Agents Physiological Effects of Drugs Contraceptives, Oral Contraceptive Agents, Female Psychotropic Drugs Hallucinogens Reproductive Control Agents Infection Pathologic Processes Sensory System Agents Therapeutic Uses Syndrome |
Contraceptives, Oral, Synthetic Analgesics Appetite Stimulants RNA Virus Infections Disease Antineoplastic Agents, Hormonal Immune System Diseases Central Nervous System Stimulants Pharmacologic Actions Analgesics, Non-Narcotic Lentivirus Infections Peripheral Nervous System Agents Central Nervous System Agents |