A Study of an Oral Entry Inhibitor, SP01A, in Treatment-Experienced HIV-Infected Patients
Public ClinicalTrials.gov record NCT00113412. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study Of Orally Administered SP01A As Monotherapy Treatment Of HIV-Infected Patients
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00113412
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 32 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 60 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 30, 2005
- Primary completion
- Not listed
- Completion
- Not listed
- Last update posted
- Mar 21, 2006
Started 2005
United States locations
- U.S. sites
- 7
- U.S. states
- 3
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Therafirst Medical Centers | Fort Lauderdale | Florida | 33308 | — |
| BioCollections Worldwide, Inc. | Miami | Florida | 33137 | — |
| Orlando Immunology Center | Orlando | Florida | 32803 | — |
| Infectious Disease Research Institute | Tampa | Florida | 33614 | — |
| Anderson Medical Group | Pittsburgh | Pennsylvania | 15206 | — |
| Tarant County Infectious Disease | Fort Worth | Texas | 76104 | — |
| University of Texas Health Science Center | Houston | Texas | 77009 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00113412, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 21, 2006 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00113412 live on ClinicalTrials.gov.