DRUG
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.
Timeline
From registration to results.
First posted
Aug 31, 2001
Study start
Not reported
Primary completion
Not reported
Study completion
Not reported
Results posted
Not reported
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.
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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.