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Entry Inhibitor

SP01A for HIV

Q: Who meets the qualifications for participation in this medical research?

<p>This clinical trial is enrolling 32 <a href="https://www.withpower.com/clinical-trials/hiv">HIV</a>-positive patients aged between 18 and 60. In order to qualify, individuals must have been off <a href="https://www.withpower.com/clinical-trials/all">all</a> anti-viral medications for a period of 4 weeks prior to the first day of study drug administration (Study Day -1). Additionally, they must have a Karnofsky score greater than or equal to 60. Lastly, for female candidates who are capable of becoming pregnant, it is necessary that they possess a negative urine <a href="https://www.withpower.com/clinical-trials/pregnancy">pregnancy</a> test at screening and agree to use two forms of <a href="https://www.withpower.com/clinical-trials/birth-control">birth control</a> throughout the duration of the study.</p>

Phase 2

Waitlist Available

Research Sponsored by Samaritan Pharmaceuticals, Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient is at least 18 years of age and not older than 60 years of age

Patient has a Karnofsky score greater than or equal to 60

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is studying a new drug, SP01A, to see if it is effective and safe in treating HIV.

Who is the study for?

This trial is for HIV-positive adults aged 18-60 who have previously been treated with antiretroviral therapy but are currently experiencing treatment failure or resistance. They must not be on any anti-viral medications for at least 4 weeks before the study, have a CD4+ count over 50 cells/ml, and a viral load above 5000 copies/ml. Women of childbearing potential must use contraception.Check my eligibility

What is being tested?

The trial tests SP01A, an oral medication that may lower HIV levels in blood and improve quality of life with minimal side effects. Participants will randomly receive one of four different doses or a placebo without knowing which they're getting to assess dose response and safety over a ten-day period.See study design

What are the potential side effects?

In previous studies, SP01A showed minimal side effects and was well tolerated. However, specific side effect details aren't provided here; participants will be monitored during the trial for any adverse reactions that occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 60 years old.

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I am able to care for myself but may need occasional help.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The primary objective of this study is to assess the dose-response, efficacy, and safety of orally administered SP01A as monotherapy treatment in HIV-infected patients with evidence of resistance to currently available antiretroviral therapy.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Samaritan Pharmaceuticals, IncLead Sponsor

2 Previous Clinical Trials

84 Total Patients Enrolled

Erasto Saldi, MDStudy DirectorSamaritan Pharmaceuticals, Inc

Media Library

SP01A (Entry Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT00113412 — Phase 2

Human Immunodeficiency Virus Infection Research Study Groups:

Human Immunodeficiency Virus Infection Clinical Trial 2023: SP01A Highlights & Side Effects. Trial Name: NCT00113412 — Phase 2

SP01A (Entry Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00113412 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the criteria for enrollment extend beyond individuals under 25 years old?

"Within the bounds of this trial's eligibility criteria, eligible patients must be aged 18 or over and no more than 60."

Answered by AI

What deleterious effects should patients be aware of when considering this treatment?

"Our evaluation of this treatment's safety resulted in a score of 2, as it is still undergoing Phase 2 trials and there is limited evidence supporting its efficacy."

Answered by AI

How widespread is the implementation of this research?

"This research trial is being conducted at 7 medical facilities, such as Therafirst Medical Centers in Fort Lauderdale and BioCollections Worldwide Inc. in Miami; additionally, Orlando Immunology Center based in Orlando are also taking part."

Answered by AI

Are there any opportunities to join this clinical research project?

"Clinicaltrials.gov reveals that this clinical trial is no longer accepting patients, as the last update to its record was on March 21st 2006. Despite not recruiting anymore, there are still 484 other trials seeking volunteers at present."

Answered by AI

Who meets the qualifications for participation in this medical research?

"This clinical trial is enrolling 32 HIV-positive patients aged between 18 and 60. In order to qualify, individuals must have been off all anti-viral medications for a period of 4 weeks prior to the first day of study drug administration (Study Day -1). Additionally, they must have a Karnofsky score greater than or equal to 60. Lastly, for female candidates who are capable of becoming pregnant, it is necessary that they possess a negative urine pregnancy test at screening and agree to use two forms of birth control throughout the duration of the study."

Answered by AI

Recent research and studies

Journal of Pharmacology and Experimental TherapeuticsJournal

Inhibition of Adrenal Cortical Steroid Formation by Procaine Is Mediated by Reduction of the Camp-induced 3-hydroxy-3-methylglutaryl-coenzyme A Reductase Messenger Ribonucleic Acid Levels

Xu, Jing, Laurent Lecanu, Zeqiu Han, Zhixing Yao, Janet Greeson, and Vassilios Papadopoulos. 2003. “Inhibition of Adrenal Cortical Steroid Formation by Procaine Is Mediated by Reduction of the Camp-induced 3-hydroxy-3-methylglutaryl-coenzyme A Reductase Messenger Ribonucleic Acid Levels”. Journal of Pharmacology and Experimental Therapeutics. American Society for Pharmacology & Experimental Therapeutics (ASPET). doi:10.1124/jpet.103.055178.

clinicaltrials.govStudy

A Study of an Oral Entry Inhibitor, SP01A, in Treatment-Experienced HIV-Infected Patients

2005. "A Study of an Oral Entry Inhibitor, SP01A, in Treatment-Experienced HIV-Infected Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00113412.

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