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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Collaborators: |
Roxane Laboratories Bristol-Myers Squibb |
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000737 |
Purpose
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 |
|---|---|---|
|
Cachexia HIV Infections HIV Wasting Syndrome |
Drug: Dronabinol Drug: Megestrol acetate |
Phase I |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics Study Masking: Open Label Primary Purpose: Treatment |
| 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.
Eligibility| 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).
Contacts and Locations| 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 |
More Information
| ClinicalTrials.gov Identifier: | NCT00000737 History of Changes |
| Other Study ID Numbers: | DATRI 004 |
| Study First Received: | November 2, 1999 |
| Last Updated: | August 22, 2008 |
| Health Authority: | United States: Federal Government |
|
Weight Loss Megestrol Cachexia |
Eating Disorders Tetrahydrocannabinol Appetite |
|
HIV Infections Acquired Immunodeficiency Syndrome Cachexia Wasting Syndrome HIV Wasting Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Emaciation |
Weight Loss Body Weight Changes Body Weight Signs and Symptoms Metabolic Diseases Nutrition Disorders Megestrol Acetate Megestrol Tetrahydrocannabinol Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Appetite Stimulants Central Nervous System Stimulants |