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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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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.

Conditions

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HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Peptide Construction 3, Synthetic

Intervention Type DRUG

Eligibility Criteria

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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:

Exclusion Criteria

Prior Medication:

Allowed:

* Prior antiretrovirals.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Brown Univ School of Medicine

Providence, Rhode Island, United States

Site Status

Countries

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United States

Other Identifiers

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SPC3-US1

Identifier Type: -

Identifier Source: secondary_id

257A