HIV InfectionsPhase 2NCT00002228
A Study of T-20 in HIV-Positive Adults
A Phase 2 study testing Enfuvirtide in people with HIV Infections, run by Trimeris at 11 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Enfuvirtide
- How many people
- 78 participants
- Where
- 11 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 21Show fewer
- 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.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
IDC Research Initiative
Altamonte Springs, Florida, 32701
Johns Hopkins Hosp
Baltimore, Maryland, 21287
Univ of Alabama at Birmingham / 1917 AIDS O/P Cln
Birmingham, Alabama, 35294
CRI of New England
Brookline, Massachusetts, 02445
Univ North Carolina at Chapel Hill / Dept of Medicine
Chapel Hill, North Carolina, 27599
Northwestern Univ / Infect Dis Div / Pasavant Pav 828
Chicago, Illinois, 60611
Univ of Texas / Thomas Street Clinic
Houston, Texas, 77030
UCLA School of Medicine / Ctr for Research and Education
Los Angeles, California, 900951793
NYU Med Ctr / C & D Building
New York, New York, 10016
San Francisco Gen Hosp
San Francisco, California, 94110
Quest Clinical Research
San Francisco, California, 94115
About this study
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
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.
Read the 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.
- Conditions
- HIV Infections
- Being tested
- Enfuvirtide
- Keywords
- Injections, Subcutaneous, HIV-1, Anti-HIV Agents, peptide T20
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnfuvirtideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Enrolment
- 78 participants
Sponsor and investigators
- Lead sponsor
- Trimeris
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Sam Hopkins, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002228
- Sponsor's protocol ID
- 295A
- Other IDs
- TRI-003
- Status last verified
- Apr 1999
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00002228
- Acronym / sponsor ID
- 295A
- Conditions
- HIV Infections
- Keywords
- Injections, Subcutaneous, HIV-1, Anti-HIV Agents, peptide T20
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants
- Lead sponsor
- TrimerisIndustry (pharma, biotech, devices)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- HIV-1 seropositive status.
Key exclusion criteria (21 listed)
- Concurrent neoplasm (except for basal cell carcinoma of the skin, in situ carcinoma of the cervix, and non-disseminated stable Kaposi's sarcoma).
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enfuvirtide | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sam Hopkins study chair
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Enfuvirtide in people with HIV Infections, run by Trimeris at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.