Current partner codePEPTIDESDE
NCT00002228·Phase 2·INTERVENTIONAL

A Study of T-20 in HIV-Positive Adults

Status

Completed

Phase

Phase 2

Enrollment

78

Locations

11

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full 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.

Interventions

Treatment arms and agents.

DRUG

Enfuvirtide

Timeline

From registration to results.

  1. First posted

    Aug 31, 2001

  2. Study start

    Not reported

  3. Primary completion

    Not reported

  4. Study completion

    Not reported

  5. Results posted

    Not reported

  6. Registry updated

    Jun 24, 2005

Outcomes

What the study measures.

Primary outcomes

Not reported in the indexed record.

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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 locations

11 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

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

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Enfuvirtide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.