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

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Key information

Conditions

HIV Infections AIDS-Related Complex Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Saint Luke's - Roosevelt Hosp Ctr

New York, 10019, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Wobenzym

Drug

Sponsors and collaborators

Lead sponsor

Mucos Pharma GmbH and Co

Industry

Registry information

Official study title

A Phase I-II Dose Escalation Study to Examine the Safety of Four Doses of Wobenzym in HIV Seropositive Patients

Important dates

First posted: Aug 31, 2001
Registry last updated: Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed