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Entry Inhibitor

SP01A for HIV/AIDS

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 has been off all antiviral medications including any unapproved or experimental treatment for at least 2 weeks prior to Study Day-1 (baseline)

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial will help determine if SP01A is an effective treatment for HIV and what side effects it might cause.

Who is the study for?

This trial is for HIV-positive adults aged 18-60 who have previously failed or resisted HIV treatments. They must not be on antiviral medications for two weeks, have a CD4+ count of at least 100 copies/mL, and a viral load over 5000 copies/mL. Women must use dual contraception or be unable to become pregnant. Excluded are those with severe kidney issues, low blood cell counts, active infections or hepatitis, cancer (except certain skin cancers), substance abuse problems, or any condition that might interfere with the study.Check my eligibility

What is being tested?

SP01A is an oral medication being tested in this placebo-controlled study to see if it can lower the amount of HIV in the blood over a period of 28 days. Participants will randomly receive either SP01A at varying doses or a placebo without knowing which one they're getting. The drug's effect on cholesterol binding suggests potential benefits against HIV replication.See study design

What are the potential side effects?

While specific side effects aren't listed here, participants should watch out for any new symptoms since SP01A could potentially cause reactions similar to other anti-HIV drugs like digestive issues, fatigue, skin rashes and changes in liver function tests.

Eligibility Criteria

Inclusion Criteria

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

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I haven't taken any antiviral medications for at least 2 weeks.

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I am between 18 and 60 years old.

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

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I am able to understand and agree to the study's procedures and risks.

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

Within treatment group reduction in viral load (log10) in each SP01A active arm as well as within the placebo arm as measured from DAY-1 (Baseline) to DAY-22, and DAY-29 (Study-End).

Secondary outcome measures

Reduction in viral load compared across SP01A active arms measured from DAY-1 (Baseline) to DAY-22 and DAY-29 (Study-End).

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Samaritan Pharmaceuticals, IncLead Sponsor

2 Previous Clinical Trials

56 Total Patients Enrolled

Robert S Musni, MDStudy DirectorMedical Director, Samaritan Pharmaceuticals

Media Library

SP01A (Entry Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT00299897 — Phase 2

Human Immunodeficiency Virus Infection Research Study Groups:

Human Immunodeficiency Virus Infection Clinical Trial 2023: SP01A Highlights & Side Effects. Trial Name: NCT00299897 — Phase 2

SP01A (Entry Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00299897 — Phase 2

Frequently Asked Questions

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

Are minors being allowed to participate in the experiment?

"According to the specifications of this clinical trial, only individuals between 18 and 60 years old can participate. There are 149 studies involving minors while 467 cover those over 65."

Answered by AI

Are there any remaining slots for individuals to partake in this trial?

"Reports on clinicaltrials.gov demonstrate that this trial, originally posted on March 1st 2006 and last edited October 25th 2006, is not presently recruiting participants. Despite this, there are 636 other studies actively seeking enrolment at the moment."

Answered by AI

Who is able to apply for inclusion in this trial?

"This clinical trial is looking to enrol 60 individuals who are between 18 and 60 years old, have a HIV infection, and satisfy several other criteria. Specifically, they must not have taken any experimental medications in the last 4 weeks; be free of antiviral medication for 2 weeks prior to baseline assessment; possess a Karnofsky score greater than or equal to 60; and female patients that are capable of becoming pregnant must provide proof of negative pregnancy test at screening as well as agree to use dual contraception from the start of study."

Answered by AI

Are there multiple sites conducting this experiment in the city?

"This research project is taking place at 5 different sites, including Beverly Hills, Fort Lauderdale and West Palm Beach. If a participant elects to enrol in the trial it would be best for them to select their closest location so as to minimize travel requirements."

Answered by AI

Has the U.S Food and Drug Administration sanctioned this medication?

"Based on our team's assessment, the safety of this treatment was rated a 2 as it is still in Phase 2 clinical trials. Therefore, there are preliminary data regarding its safety but no evidence for efficacy yet."

Answered by AI