Completed
Daily Intravenous SPC3 Doses for HIV-1 Seropositive Patients
Study Aim
This study aims to evaluate the safety and effectiveness of daily intravenous SPC3 doses as a treatment for individuals who are HIV-1 seropositive.
What is being tested
Peptide Construction 3, Synthetic
Drug
Who is being recruted
Blood-Borne Infections+14
+ Urogenital Diseases
+ Genital Diseases
From 18 to 65 Years
+10 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 1
Interventional
Summary
Principal SponsorColumbia Research Laboratories
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
The first five patients receive SPC3 daily for 3 weeks. If that dose is tolerated, the dose is increased and given to the next 5 patients for 3 weeks. The remaining ten patients receive a dose of SPC3 based on response to the previous two dose levels. Patients are followed through day 28.
Principal SponsorColumbia Research Laboratories
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.Design Details
20 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.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.From 18 to 65 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
6 inclusion criteria required to participate
Antiretrovirals provided regimen has been stable for at least 6 weeks prior to study screening
CD4 >= 100 cells/mm3
HIV RNA PCR (Amplicor) > 10,000 copies/ml
HIV seropositivity for at least 6 months
Show More Criteria
4 exclusion criteria prevent from participating
Any drug that may interact with SPC3 (e.g., suramin)
History of relevant drug hypersensitivity
Inability to communicate with investigator or deemed likely to be noncompliant on study
Investigational drug within the past 4 weeks
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
Brown Univ School of Medicine
Providence, United StatesOpen Brown Univ School of Medicine in Google MapsCompletedOne Study Center