A Study of T-20 in HIV-Positive Adults

Sponsor

Trimeris (Industry)

Overall Status

Completed

CT.gov ID

NCT00002228

Collaborator

(none)

Enrollment

Locations

7.1

Patients Per Site

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Enfuvirtide	Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 0 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Univ of Alabama at Birmingham / 1917 AIDS O/P Cln	Birmingham	Alabama	United States	35294
2	UCLA School of Medicine / Ctr for Research and Education	Los Angeles	California	United States	900951793
3	San Francisco Gen Hosp	San Francisco	California	United States	94110
4	Quest Clinical Research	San Francisco	California	United States	94115
5	IDC Research Initiative	Altamonte Springs	Florida	United States	32701
6	Northwestern Univ / Infect Dis Div / Pasavant Pav 828	Chicago	Illinois	United States	60611
7	Johns Hopkins Hosp	Baltimore	Maryland	United States	21287
8	CRI of New England	Brookline	Massachusetts	United States	02445
9	NYU Med Ctr / C & D Building	New York	New York	United States	10016
10	Univ North Carolina at Chapel Hill / Dept of Medicine	Chapel Hill	North Carolina	United States	27599
11	Univ of Texas / Thomas Street Clinic	Houston	Texas	United States	77030