Search Clinical Trials
 
By Condition
 
By Location (USA)
 
By Location (Other)
 
By Sponsor
 
Resources
 
Privacy Policy
 
About Us
Disclaimer
The Safety and Effectiveness of SPC3 in HIV-1 Infected Patients Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about The Safety and Effectiveness of SPC3 in HIV-1 Infected Patients conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. The Safety and Effectiveness of SPC3 in HIV-1 Infected Patients Clinical research trials and The Safety and Effectiveness of SPC3 in HIV-1 Infected Patients healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as The Safety and Effectiveness of SPC3 in HIV-1 Infected Patients. The Safety and Effectiveness of SPC3 in HIV-1 Infected Patients Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a The Safety and Effectiveness of SPC3 in HIV-1 Infected Patients clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their The Safety and Effectiveness of SPC3 in HIV-1 Infected Patients condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.

Home > "T" Clinical Trials Conditions > The Safety and Effectiveness of SPC3 in HIV-1 Infected Patients

The Safety and Effectiveness of SPC3 in HIV-1 Infected Patients



The Safety and Effectiveness of SPC3 in HIV-1 Infected Patients

For Condition: HIV Infections
Status: Completed
Sponsor(s): Columbia Research Laboratories ,
Synopsis: To assess the effects of two doses of synthetic peptide construction 3 ( SPC3 ) on HIV-1 plasma levels (as measured by RNA PCR Amplicor) and on lymphocyte subsets in patients with initial viral load above 10,000 copies/ml. To study the safety of SPC3 and the kinetics of HIV-1 plasma level changes.
Details: 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.
Eligibility:
Study Type:  Interventional, Treatment, Dose Comparison, Pharmacokinetics Study
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Antiretrovirals provided regimen has been stable for at least 6 weeks prior to study screening. Patients must have: - HIV seropositivity for at least 6 months. - CD4 >= 100 cells/mm3. - HIV RNA PCR (Amplicor) > 10,000 copies/ml. - No significant active opportunistic infection or tumor at study entry. FDA DISCLAIMER: - The FDA encourages the inclusion of females of childbearing potential in study protocols, but the sponsor of this protocol specifically excludes females of childbearing potential from this study and includes only females who are sterile. Any questions about these inclusion/exclusion criteria should be directed to the study's contact person. Prior Medication: Allowed: - Prior antiretrovirals. Exclusion Criteria Co-existing Condition: Patients with the following conditions are excluded: Inability to communicate with investigator or deemed likely to be noncompliant on study. Concurrent Medication: Excluded: - Any drug that may interact with SPC3 (e.g., suramin). Patients with the following prior condition are excluded: History of relevant drug hypersensitivity. Prior Medication: Excluded: - Investigational drug within the past 4 weeks.
Total Enrollment: 20

Location and Contact Information:

Brown Univ School of Medicine
Providence,  Rhode Island,  02908
United States
 


Additional Information:
Study ID Numbers:  257A;  SPC3-US1
Study Start Date: 
Record last reviewed: April 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002363

Other Hiv Infections Studies:
1. A Study to See if Certain Antioxidants and Vitamins Will Keep Lactate Levels Down in Patients Taking Anti-HIV Drugs

2. A Phase I Study of Recombinant Human CD4 Immunoglobulin G (rCD4-lgG) in Patients with HIV-Associated Immune Thrombocytopenic Purpura

3. Safety and Effectiveness of Lamivudine When Given Once a Day versus Twice a Day in Combination with Other Anti-HIV Drugs in HIV-Infected Adults Who Have Never Received Anti-HIV Drugs

4. A Phase II/III Trial of Human Anti-CMV Monoclonal Antibody MSL 109 (MACRT)

5. Intracellular Pharmacokinetics of Zidovudine Triphosphate in Maternal and Infant Cord Blood Mononuclear Cells.

Related Studies:

Other HIV Infections Clinical Trials
Other Rhode Island Clinical Trials
Other Providence Clinical Trials

The Safety and Effectiveness of SPC3 in HIV-1 Infected Patients
Modify your Search

  Other HIV Infections Clinical Trials
  Other Rhode Island Clinical Trials
  Other Providence Clinical Trials


Warning: include(/var/www/cgi-bin/traxis/counter.php) [function.include]: failed to open stream: No such file or directory in /home/cts/domains/clinicaltrialssearch.org/public_html/index.php on line 103

Warning: include() [function.include]: Failed opening '/var/www/cgi-bin/traxis/counter.php' for inclusion (include_path='.:/usr/local/lib/php') in /home/cts/domains/clinicaltrialssearch.org/public_html/index.php on line 103