A Study of T-20 in HIV-Positive Adults

Completed · Phase 2

Conditions studied: HIV Infections

In brief

The purpose of this study is to see if it is safe and effective to give T-20 to HIV-positive adults. T-20 is an anti-HIV drug.

Key facts

Study ID

NCT00002228

Run by

Trimeris

People needed

78

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Univ of Alabama at Birmingham / 1917 AIDS O/P Cln — Birmingham, Alabama, United States
• UCLA School of Medicine / Ctr for Research and Education — Los Angeles, California, United States
• San Francisco Gen Hosp — San Francisco, California, United States
• Quest Clinical Research — San Francisco, California, United States
• IDC Research Initiative — Altamonte Springs, Florida, United States
• Northwestern Univ / Infect Dis Div / Pasavant Pav 828 — Chicago, Illinois, United States
• Johns Hopkins Hosp — Baltimore, Maryland, United States
• CRI of New England — Brookline, Massachusetts, United States
• NYU Med Ctr / C & D Building — New York, New York, United States
• Univ North Carolina at Chapel Hill / Dept of Medicine — Chapel Hill, North Carolina, United States
• Univ of Texas / Thomas Street Clinic — Houston, Texas, United States

Full record on ClinicalTrials.gov

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