A Study of T-20 in HIV-Positive Adults

HIV Infections Clinical Trial

Official title:

A Phase II Evaluation of the Safety, Plasma Pharmacokinetics, and Antiviral Activity of T-20 Administered to HIV-1 Positive Adults By Continuous Subcutaneous Infusion or Subcutaneous Injection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002228
• Other study ID #: 295A
• Secondary ID: TRI-003
• Status: Completed
• Phase: Phase 2
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: April 1999
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Pharmacokinetics Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Enfuvirtide

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Trimeris

Country where clinical trial is conducted

United States,