The Safety of Four Different Dose Levels of Wobenzym in HIV-Positive Patients

This study has been completed.

First Received: November 2, 1999 Last Updated: June 23, 2005 History of Changes

Sponsored by:	Mucos Pharma GmbH and Co
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002311

Purpose

To study the safety and efficacy of four different doses of Wobenzym (an enzyme combination consisting of pancreatin, papain, bromelain, trypsin, lipase, amylase, chymotrypsin, and rutin) in patients with HIV infection whose CD4 count is between 250 and 400 cells/mm3. To evaluate the effect of Wobenzym on certain surrogate markers associated with progression of HIV disease.

Condition	Intervention	Phase
HIV Infections	Drug: Wobenzym	Phase I

MedlinePlus related topics: AIDS

Drug Information available for: Wobenzym

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Dose Comparison, Pharmacokinetics Study
Official Title:	A Phase I-II Dose Escalation Study to Examine the Safety of Four Doses of Wobenzym in HIV Seropositive Patients

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

Patients must have:

HIV seropositivity with CD4 counts between 250 and 400 cells/mm3.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

Known hypersensitivity to hydrolytic enzymes such as Wobenzym.
Known sensitivity to lactose.
Presumption that the patient will not comply with the dosing schedule or follow-up appointments.

Concurrent Medication:

Excluded:

Concurrent use of immunosuppressive therapy or steroids.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002311

Locations

United States, New York
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, United States, 10019

Sponsors and Collaborators

Mucos Pharma GmbH and Co

More Information

No publications provided

Study ID Numbers:	122A
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002311 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Wobenzym
Hydrolases

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
Immunologic Factors
HIV Seropositivity
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Adjuvants, Immunologic
Wobenzym
AIDS-Related Complex
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Acquired Immunodeficiency Syndrome
Adjuvants, Immunologic
Wobenzym

Infection
Pharmacologic Actions
Immunologic Deficiency Syndromes
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on May 07, 2009