Status:

COMPLETED

A Phase I/II Study to Evaluate Single Agent and Combination Therapy With Megestrol Acetate and Dronabinol for the Treatment of HIV-Wasting Syndrome

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborating Sponsors:

Roxane Laboratories

Bristol-Myers Squibb

Conditions:

Cachexia

HIV Infections

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief 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. To obtain prelim...

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 pro...

Eligibility 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).

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

Estimated Enrollment :

56 Patients enrolled

Trial Details

Trial ID

NCT00000737

Last Update

August 25 2008

Active Locations (9)

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Page 1 of 3 (9 locations)

1

Denver Public Health Dept

Denver, Colorado, United States, 802044507

2

Univ of Illinois

Chicago, Illinois, United States, 60612

3

Univ of Kansas School of Medicine

Wichita, Kansas, United States, 67214

4

Tulane Univ Med School

New Orleans, Louisiana, United States, 701122699