Search / Trial NCT00002228

A Study of T-20 in HIV-Positive Adults

Launched by TRIMERIS · Aug 30, 2001

Trial Information

Current as of December 07, 2024

Completed

Keywords

Injections, Subcutaneous Hiv 1 Anti Hiv Agents Peptide T20

ClinConnect Summary

Patients are randomly placed into 1 of 6 groups: 4 dose levels of T-20 are given by subcutaneous infusion and 2 by subcutaneous injection. The entire study lasts 7 weeks; including a 2-week screening period, followed by 28 days of treatment and 1 week of follow-up.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • Any antiretroviral agent, provided the regimen has not changed within 6 weeks of the screening visit.
  • Antibiotics for bacterial infections.
  • Prophylactic medications for P. carinii pneumonia and for M. avium, including azithromycin.
  • Medications for symptomatic treatment such as antipyretics, analgesics, and antiemetics.
  • Patients must have:
  • HIV-1 seropositive status.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Concurrent neoplasm (except for basal cell carcinoma of the skin, in situ carcinoma of the cervix, and non-disseminated stable Kaposi's sarcoma).
  • Concurrent Medication:
  • Excluded:
  • Patients must not be taking any concurrent antiretroviral therapy (for at least 2 weeks prior to baseline) or the patient is to be on a stable antiretroviral regimen which has not changed for at least 6 weeks prior to baseline.
  • * Treatment with any of the following:
  • immunomodulators, biological response modifiers, chemotherapy that cannot be discontinued for the duration of the study, astemizole, terfenadine, cisapride, triazolam, midazolam, rifampin, clarithromycin, or an investigational drug within 30 days prior to the initial visit.
  • Patients with the following prior conditions are excluded:
  • Evidence of active opportunistic infections, or unexplained temperature greater than or equal to 38.5 Celsius for 7 consecutive days within 30 days prior to screening visit.
  • Chronic diarrhea (defined as greater than 3 liquid stools per day which persists for 15 days) within 30 days prior to screening visit.
  • Diagnosis of hemophilia or other clotting disorders.
  • Prior Medication:
  • Excluded:
  • - Prior treatment with an HIV vaccine.
  • Prior Treatment:
  • Excluded:
  • Major organ allograft.
  • Risk Behavior:
  • Excluded:
  • Evidence of substance abuse or addiction that, in the opinion of the investigator, may interfere with the patient's ability to comply with the dosing schedule and protocol evaluations.

Trial Officials

Sam Hopkins

Study Chair

About Trimeris

Trimeris is a biopharmaceutical company dedicated to the development of innovative therapeutic solutions for viral infections, with a strong focus on advancing treatments for HIV and other infectious diseases. Renowned for its commitment to research and development, Trimeris leverages cutting-edge technology and scientific expertise to create novel antiviral therapies that aim to improve patient outcomes and quality of life. Through rigorous clinical trials and collaboration with healthcare professionals, Trimeris strives to bring effective treatments to market, addressing unmet medical needs and enhancing global health.

Locations

San Francisco, California, United States

Baltimore, Maryland, United States

Brookline, Massachusetts, United States

Altamonte Springs, Florida, United States

Birmingham, Alabama, United States

Los Angeles, California, United States

San Francisco, California, United States

Chicago, Illinois, United States

New York, New York, United States

Chapel Hill, North Carolina, United States

Houston, Texas, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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