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

This study has been completed.

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

Sponsor:	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

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

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Wobenzym

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

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

ClinicalTrials.gov Identifier:	NCT00002311 History of Changes
Other Study ID Numbers:	122A
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
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

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency 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
Wobenzym
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012