- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002311
The Safety of Four Different Dose Levels of Wobenzym in HIV-Positive Patients
June 23, 2005 updated by: Mucos Pharma GmbH and Co
A Phase I-II Dose Escalation Study to Examine the Safety of Four Doses of Wobenzym in HIV Seropositive Patients
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.
Study Overview
Study Type
Interventional
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10019
- Saint Luke's - Roosevelt Hosp Ctr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
November 2, 1999
First Submitted That Met QC Criteria
August 30, 2001
First Posted (Estimate)
August 31, 2001
Study Record Updates
Last Update Posted (Estimate)
June 24, 2005
Last Update Submitted That Met QC Criteria
June 23, 2005
Last Verified
May 1, 1993
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Physiological Effects of Drugs
- Immunologic Factors
- Adjuvants, Immunologic
- Wobenzym
Other Study ID Numbers
- 122A
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on HIV Infections
-
University of MinnesotaWithdrawnHIV Infections | HIV/AIDS | Hiv | AIDS | Aids/Hiv Problem | AIDS and InfectionsUnited States
-
University of California, San DiegoUniversity of California, Los Angeles; University of Southern California; California... and other collaboratorsCompleted
-
National Institute of Allergy and Infectious Diseases...Eunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedHIV Infections | HIV SeronegativityUnited States, Puerto Rico
-
Gérond'ifRecruiting
-
University of California, DavisCompleted
-
University of California, San DiegoNational Center for Complementary and Integrative Health (NCCIH)CompletedHIV PositiveUnited States
-
University of ChicagoUniversity of Athens; National Development and Research Institutes, Inc.Completed
-
HIV Prevention Trials NetworkNational Institute on Drug Abuse (NIDA); National Institute of Allergy and...CompletedHIV PositiveIndonesia, Ukraine, Vietnam
-
University of ZimbabweCompleted
-
Florida International UniversityCompleted
Clinical Trials on Wobenzym
-
Mucos Pharma GmbH & Co. KGNestlé; ArtialisCompleted
-
Mucos Pharma GmbH & Co. KGCompletedThrombophlebitis LegItaly
-
Mucos Pharma GmbH & Co. KGCompletedMuscle Soreness | Muscle Injury | Exercise Induced Muscle DamageGermany
-
Laval UniversityAtrium InnovationsCompleted
-
Atrium InnovationsWithdrawnKnee OsteoarthritisCanada
-
Technical University of MunichCompletedPathologic Processes | Heart Diseases | Cardiovascular Diseases | Respiratory Tract Infections | Inflammation | Blood Coagulation Disorders | Death | Death, Sudden | Death, Sudden, CardiacGermany
-
BayerCompletedOsteoporosis | Hypogonadism | Paraplegia | Bone DensityGermany
-
Atrium InnovationsMucos Pharma GmbH, Oberhaching, GermanyCompletedOsteoarthritis | WobenzymGermany