Completed
Safety and Efficacy of Four Doses of Wobenzym in HIV Patients with CD4 Count Between 250 and 400 cells/mm3
What is being tested
Wobenzym
Drug
Who is being recruted
Blood-Borne Infections+14
+ Urogenital Diseases
+ Genital Diseases
Over 18 Years
+5 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 1
Interventional
Summary
Principal SponsorMucos Pharma GmbH and Co
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
This study focuses on understanding the safety and effectiveness of a drug called Wobenzym in individuals who have HIV infection. Wobenzym is a mix of various enzymes such as pancreatin, papain, bromelain, trypsin, lipase, amylase, chymotrypsin, and rutin. The study targets people with HIV whose CD4 count, a measure of immune system health, ranges from 250 to 400 cells/mm3. The main goal of the study is to investigate if Wobenzym could potentially slow down the progression of HIV disease, addressing an important need in HIV care.
Principal SponsorMucos Pharma GmbH and Co
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsAcquired Immunodeficiency SyndromeAIDS-Related ComplexHIV Infections
Criteria
1 inclusion criteria required to participate
HIV seropositivity with CD4 counts between 250 and 400 cells/mm3
4 exclusion criteria prevent from participating
Concurrent use of immunosuppressive therapy or steroids
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Saint Luke's - Roosevelt Hosp Ctr
New York, United StatesOpen Saint Luke's - Roosevelt Hosp Ctr in Google MapsCompletedOne Study Center