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Home > "A" Clinical Trials Conditions > A Study of T-20 in HIV-Positive Adults  A Study of T-20 in HIV-Positive Adults
A Study of T-20 in HIV-Positive Adults
For Condition: HIV Infections
Status: Completed
Sponsor(s): Trimeris ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Pharmacokinetics Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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.
Total Enrollment: 78
Location and Contact Information:
Overall Study Official:
SamHopkins, Study Chair,
Northwestern Univ / Infect Dis Div / Pasavant Pav 828
Chicago, Illinois, 60611
United States
Univ of Alabama at Birmingham / 1917 AIDS O/P Cln
Birmingham, Alabama, 35294
United States
IDC Research Initiative
Altamonte Springs, Florida, 32701
United States
San Francisco Gen Hosp
San Francisco, California, 94110
United States
Quest Clinical Research
San Francisco, California, 94115
United States
CRI of New England
Brookline, Massachusetts, 02445
United States
Univ North Carolina at Chapel Hill / Dept of Medicine
Chapel Hill, North Carolina, 27599
United States
UCLA School of Medicine / Ctr for Research and Education
Los Angeles, California, 900951793
United States
NYU Med Ctr / C & D Building
New York City, New York, 10016
United States
Univ of Texas / Thomas Street Clinic
Houston, Texas, 77030
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
Additional Information:
Study ID Numbers: 295A; TRI-003
Study Start Date:
Record last reviewed: April 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002228
Other Hiv Infections Studies:
1. A Study of Rifabutin, Used Alone or with Ethambutol in the Prevention of Mycobacterium avium Complex (MAC) Bacteremia in Patients with AIDS
2. A Placebo-Controlled, Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Envelope Proteins of HIV-1 gp160 and gp120 in Children >= 1 Month Old With Asymptomatic HIV Infection
3. Evaluation of the Safety and Tolerance of Immunotherapy With Autologous, Ex-Vivo Expanded, HIV-Specific Cytotoxic T-Cells in HIV-Infected Patients With CD4+ Counts Between 100-400/mm3
4. A Pilot Study of the Short-Term Effects of Antiretroviral Management Based on Plasma Genotypic Antiretroviral Resistance Testing (GART) Compared With Antiretroviral Management Without Plasma GART
5. A Study of Foscarnet in the Treatment of HIV Infection in Patients Who Have Taken Zidovudine for a Long Time
Related Studies:
Other HIV Infections Clinical Trials
Other Massachusetts Clinical Trials
Other Brookline Clinical Trials
A Study of T-20 in HIV-Positive Adults
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