HIV InfectionsPhase 2NCT00113412
A Study of an Oral Entry Inhibitor, SP01A, in Treatment-Experienced HIV-Infected Patients
A Phase 2 study testing SP01A in people with HIV Infections, run by Samaritan Pharmaceuticals, Inc at 7 sites in United States.
Trial summary
One measurement of an HIV infected person's risk of progressing to AIDS is the number of viral particles of HIV in their blood (called a "viral load"). In a previous phase I/II study, SP01A was observed to significantly lower the amount of HIV in blood, improve quality of life (how well subject's felt), have a… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- SP01A
- How many people
- 32 participants
- Where
- 7 sitesUnited States
- Study dates
- May 2005to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- To be eligible for inclusion into this study, patients must fulfill the following criteria prior to the first day of study drug (i.e. Study Day-1) unless otherwise noted.
- Patient must be capable of giving informed consent. The principal investigator or study nurse will be responsible for obtaining written informed consent from potential patients prior to conducting any testing for the screening visit.
- 2. Patient is HIV-positive and has treatment-experienced virologic failure or documented resistance. Treatment-experienced virologic failure is defined as patients meeting the following criteria; (1) previous experience with antiretroviral therapy from at least two of the approved antiretroviral classes (i.e. treatment with a nucleoside reverse transcriptase inhibitor, and/or non-nucleoside reverse transcriptase inhibitor, and/or protease inhibitor) for three to six months; (2) increasing HIV RNA after treatment had previously lowered viral load to low or undetectable levels; (3) increasing viremia (HIV RNA > 5,000 copies/mL) in at least two viral load tests confirming their failing regimen. A patient does not need to currently be on therapy. A patient that is currently on a stable antiretroviral regimen that is successfully suppressing or maintaining viremia at low detectable levels (HIV RNA < 5,000 copies/mL) is not eligible for entry into the study.
- Patient has been off all anti-viral medications, including any unapproved or experimental treatment for HIV and antiretrovirals, for at least 4 weeks prior to Study Day-1 (baseline). The patient may initiate this 4 week period after screening, if, in the judgment of the principal investigator, the patient qualifies for the study.
- Patient is at least 18 years of age and not older than 60 years of age.
- Patient is capable of adhering to the protocol.
Show all 10Show fewer
- Patient has a CD4+ count >50 cells/ml.
- Patient has a viral load of > 5000 copies/ml.
- Patient has a Karnofsky score greater than or equal to 60.
- Female patients that are of childbearing potential: (1) have a negative urine pregnancy test at screening, and agree to use a condom and another form of contraception from the start of the study; or (2) are incapable of becoming pregnant.
Who cannot join
- Patients are ineligible to participate in the study if ANY of the following criteria are met.
- Patients with known or suspected allergy to procaine hydrochloride.
- Patients using sulfonamides (including Septra/Bactrim). Sulfonamides should not be used while on SP01A, because procaine will inactivate it. If a patient must be treated with Septra/Bactrim, that patient will be removed from the study.
- Patients with glaucoma using anti-cholinesterase inhibitors (Humorsol [demecarium bromide] echothiophate iodide, Floropryl [isoflurophate], Isopto-Eserine [physostigmine salicylate]). Anti-cholinesterase inhibitors should not be used while on SP01A, since anticholinesterases inhibit the breakdown of procaine hydrochloride.
- Patients with SGOT baseline value >3 times upper limit.
- Patients with SGPT baseline value >3 times upper limit.
Show all 19Show fewer
- Patients with creatinine >2.0 mg/ dl.
- Patients with absolute neutrophil count <1,000 cells/mm3.
- Patients with platelets baseline value <75,000 cells/µl.
- Patients that currently have any active opportunistic infection. Prophylaxis for Mycobacterium avium intracellulare (MAI), cytomegalovirus (CMV), Pneumocystis carinii pneumonia (PCP), or herpes is permitted (excluding treatment with Sulfonamides).
- Females that are pregnant or breast feeding.
- Female patients of childbearing age who cannot either use dual contraception or abstain from sexual intercourse during the clinical study.
- Patients with less than 6 months life expectancy.
- Patients with active hepatitis (viral or drug induced).
- Patients with cancer, except peripheral (dermal) Kaposi's sarcoma.
- Patients on dialysis.
- Patients that currently have an active alcohol or substance abuse problem.
- Patients with any medical, psychological, psychiatric or substance use problem that, in the opinion of the principal investigator, will interfere with the patient's ability to complete the study.
- A patient that is currently on a stable antiretroviral regimen that is successfully suppressing or maintaining viremia at low detectable levels (HIV RNA < 5,000 copies/ml) is not eligible for entry into the study.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Therafirst Medical Centers
Fort Lauderdale, Florida, 33308
Tarant County Infectious Disease
Fort Worth, Texas, 76104
University of Texas Health Science Center
Houston, Texas, 77009
BioCollections Worldwide, Inc.
Miami, Florida, 33137
Orlando Immunology Center
Orlando, Florida, 32803
Anderson Medical Group
Pittsburgh, Pennsylvania, 15206
Infectious Disease Research Institute
Tampa, Florida, 33614
About this study
Official title: A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study Of Orally Administered SP01A As Monotherapy Treatment Of HIV-Infected Patients
One measurement of an HIV infected person's risk of progressing to AIDS is the number of viral particles of HIV in their blood (called a "viral load"). In a previous phase I/II study, SP01A was observed to significantly lower the amount of HIV in blood, improve quality of life (how well subject's felt), have a favorable safety profile (minimal side effects), and be well tolerated. Moreover, in in vitro testing SP01A: (1) demonstrated comparable or greater efficacy than currently approved anti-HIV drugs in preventing HIV virus replication; (2) was observed to have minimal toxic effect on human cells; and (3) demonstrated significant efficacy in preventing virus replication of HIV virus strains that resist currently approved anti-HIV treatments. Based on these results, SP01A demonstrates promise as a new and novel anti-HIV treatment.
The goal of this study is to further look at the dose response, efficacy, and safety of SP01A as monotherapy, given as a capsule to be swallowed, in the treatment of HIV-infected subjects. The investigators want to see if SP01A will lower the amount of HIV in blood.
Read more
Subjects will be assigned by chance to 1 of 4 groups. Neither the subject nor the study doctor or nurse will know which dose of the study drug the subject is taking or if the subject is receiving the placebo (a capsule that looks like the study drug but does not contain any active ingredient).
At the end of the 10-day study, the subject will be offered testing of their virus for resistance to approved drugs (genotype) and transferred to their physician for continued treatment with FDA-approved antiretroviral therapies. If the subject experiences a side effect, which continues past the end of the study, they will be further monitored until the side effect goes away.
Read the detailed description
This is a multi-center, double-blind, randomized, placebo controlled Phase II study of orally administered SP01A as monotherapy treatment in HIV-infected patients with evidence of resistance to currently available antiretroviral therapy. This monotherapy study focuses on HIV-infected subjects who have previously failed antiretroviral regimens (treatment failures; defined as individuals with evidence of their viral load going up despite taking their anti-HIV drugs precisely as prescribed).
HIV-positive subjects will be evaluated during the pre-study period. Following a 4-week washout period (to ensure that any previous anti-HIV drug no longer remains in their system), all study groups will initiate the 10-day monotherapy study.
At the conclusion of the 10-day monotherapy study, subjects will have the option of having testing to determine the best anti-HIV treatment combination for their further treatment. Further treatment, if indicated, will be limited to FDA-approved anti-HIV treatments.
The primary objective of this study is to assess the dose-response, efficacy and safety of orally administered SP01A as monotherapy treatment (study drug alone) of HIV-infected subjects with evidence of resistance to currently available anti-HIV drug therapy.
The primary analysis is the reduction in viral load (log10) within each SP01A study arm as well as within the placebo arm as measured from the first day of drug administration (DAY-1 (Baseline)) to the last day of study drug administration (DAY-11 (Study-End)).
The secondary analysis is the reduction in viral load (log10) across SP01A active arms measured from DAY-1 (Baseline) to DAY-11 (Study-End).
The investigators may also test the HIV in each patient's blood to determine if one or more HIV strains exists that are resistant to currently approved anti-HIV drugs. This testing will be conducted at DAY-1 and Day-11. Additionally, the investigators may test to determine whether the virus develops resistance to the study drug on DAY-11.
Safety will be assessed at each visit by laboratory evaluations, physical examination and/or questioning for side effects. In the event of side effects, dosing of study drug may be stopped according to provisions outlined in the protocol.
- Conditions
- HIV Infections
- Being tested
- SP01A
- Keywords
- HIV, Treatment Experienced
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SP01ADrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2005 (estimated)
- Study startMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 32 participants
Sponsor and investigators
- Lead sponsor
- Samaritan Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Erasto Saldi, MD, Study director, Samaritan Pharmaceuticals, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00113412
- Sponsor's protocol ID
- SP01A-105-04
- Status last verified
- Mar 2006
- First submitted
- 7 Jun 2005
- Last updated
- 22 Mar 2006
- Results posted
- No
Publications
Xu J, Lecanu L, Han Z, Yao Z, Greeson J, Papadopoulos V. 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. J Pharmacol Exp Ther. 2003 Dec;307(3):1148-57. doi: 10.1124/jpet.103.055178. Epub 2003 Oct 14.
PubMed 14560037
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study Of Orally Administered SP01A As Monotherapy Treatment Of HIV-Infected Patients
- ClinicalTrials.gov ID
- NCT00113412
- Acronym / sponsor ID
- SP01A-105-04
- Conditions
- HIV Infections
- Keywords
- HIV, Treatment Experienced
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants
- Lead sponsor
- Samaritan Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- May 2005
- First posted
- 8 Jun 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
One measurement of an HIV infected person's risk of progressing to AIDS is the number of viral particles of HIV in their blood (called a "viral load"). In a previous phase I/II study, SP01A was observed to significantly lower the amount of HIV in blood, improve quality of life (how well subject's felt), have a favorable safety profile (minimal side effects), and be well tolerated. Moreover, in in vitro testing SP01A: (1) demonstrated comparable or greater efficacy than currently approved anti-HIV drugs in preventing HIV virus replication; (2) was observed to have minimal toxic effect on human cells; and (3) demonstrated significant efficacy in preventing virus replication of HIV virus strains that resist currently approved anti-HIV treatments. Based on these results, SP01A demonstrates promise as a new and novel anti-HIV treatment.
The goal of this study is to further look at the dose response, efficacy, and safety of SP01A as monotherapy, given as a capsule to be swallowed, in the treatment of HIV-infected subjects. The investigators want to see if SP01A will lower the amount of HIV in blood.
Subjects will be assigned by chance to 1 of 4 groups. Neither the subject nor the study doctor or nurse will know which dose of the study drug the subject is taking or if the subject is receiving the placebo (a capsule that looks like the study drug but does not contain any active ingredient).
At the end of the 10-day study, the subject will be offered testing of their virus for resistance to approved drugs (genotype) and transferred to their physician for continued treatment with FDA-approved antiretroviral therapies. If the subject experiences a side effect, which continues past the end of the study, they will be further monitored until the side effect goes away.
Detailed description
This is a multi-center, double-blind, randomized, placebo controlled Phase II study of orally administered SP01A as monotherapy treatment in HIV-infected patients with evidence of resistance to currently available antiretroviral therapy. This monotherapy study focuses on HIV-infected subjects who have previously failed antiretroviral regimens (treatment failures; defined as individuals with evidence of their viral load going up despite taking their anti-HIV drugs precisely as prescribed).
HIV-positive subjects will be evaluated during the pre-study period. Following a 4-week washout period (to ensure that any previous anti-HIV drug no longer remains in their system), all study groups will initiate the 10-day monotherapy study.
At the conclusion of the 10-day monotherapy study, subjects will have the option of having testing to determine the best anti-HIV treatment combination for their further treatment. Further treatment, if indicated, will be limited to FDA-approved anti-HIV treatments.
The primary objective of this study is to assess the dose-response, efficacy and safety of orally administered SP01A as monotherapy treatment (study drug alone) of HIV-infected subjects with evidence of resistance to currently available anti-HIV drug therapy.
The primary analysis is the reduction in viral load (log10) within each SP01A study arm as well as within the placebo arm as measured from the first day of drug administration (DAY-1 (Baseline)) to the last day of study drug administration (DAY-11 (Study-End)).
The secondary analysis is the reduction in viral load (log10) across SP01A active arms measured from DAY-1 (Baseline) to DAY-11 (Study-End).
The investigators may also test the HIV in each patient's blood to determine if one or more HIV strains exists that are resistant to currently approved anti-HIV drugs. This testing will be conducted at DAY-1 and Day-11. Additionally, the investigators may test to determine whether the virus develops resistance to the study drug on DAY-11.
Safety will be assessed at each visit by laboratory evaluations, physical examination and/or questioning for side effects. In the event of side effects, dosing of study drug may be stopped according to provisions outlined in the protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- To be eligible for inclusion into this study, patients must fulfill the following criteria prior to the first day of study drug (i.e. Study Day-1) unless otherwise noted.
- Patient must be capable of giving informed consent. The principal investigator or study nurse will be responsible for obtaining written informed consent from potential patients prior to conducting any testing for the screening visit.
- 2. Patient is HIV-positive and has treatment-experienced virologic failure or documented resistance. Treatment-experienced virologic failure is defined as patients meeting the following criteria; (1) previous experience with antiretroviral therapy from at least two of the approved antiretroviral classes (i.e. treatment with a nucleoside reverse transcriptase inhibitor, and/or non-nucleoside reverse transcriptase inhibitor, and/or protease inhibitor) for three to six months; (2) increasing HIV RNA after treatment had previously lowered viral load to low or undetectable levels; (3) increasing viremia (HIV RNA > 5,000 copies/mL) in at least two viral load tests confirming their failing regimen. A patient does not need to currently be on therapy. A patient that is currently on a stable antiretroviral regimen that is successfully suppressing or maintaining viremia at low detectable levels (HIV RNA < 5,000 copies/mL) is not eligible for entry into the study.
- Patient has been off all anti-viral medications, including any unapproved or experimental treatment for HIV and antiretrovirals, for at least 4 weeks prior to Study Day-1 (baseline). The patient may initiate this 4 week period after screening, if, in the judgment of the principal investigator, the patient qualifies for the study.
- Patient is at least 18 years of age and not older than 60 years of age.
Key exclusion criteria (19 listed)
- Patients are ineligible to participate in the study if ANY of the following criteria are met.
- Patients with known or suspected allergy to procaine hydrochloride.
- Patients using sulfonamides (including Septra/Bactrim). Sulfonamides should not be used while on SP01A, because procaine will inactivate it. If a patient must be treated with Septra/Bactrim, that patient will be removed from the study.
- Patients with glaucoma using anti-cholinesterase inhibitors (Humorsol [demecarium bromide] echothiophate iodide, Floropryl [isoflurophate], Isopto-Eserine [physostigmine salicylate]). Anti-cholinesterase inhibitors should not be used while on SP01A, since anticholinesterases inhibit the breakdown of procaine hydrochloride.
- Patients with SGOT baseline value >3 times upper limit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SP01A | Drug | – |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2006.
- Background: PubMed 14560037Xu J, Lecanu L, Han Z, Yao Z, Greeson J, Papadopoulos V. 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. J Pharmacol Exp Ther. 2003 Dec;307(3):1148-57. doi: 10.1124/jpet.103.055178. Epub 2003 Oct 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erasto Saldi, MD study director
Samaritan Pharmaceuticals, Inc
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SP01A in people with HIV Infections, run by Samaritan Pharmaceuticals, Inc at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00113412, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2006.