HIV InfectionsPhase 2NCT00002239
A Study to Compare Three Doses of T-20 When Given in Combination With Abacavir, Amprenavir, Ritonavir, and Efavirenz to HIV-Infected Adults
A Phase 2 study testing Enfuvirtide, Ritonavir and Abacavir sulfate in people with HIV Infections, run by Hoffmann-La Roche at 20 sites in United States.
Trial summary
The purpose of this study is to see if it is safe and effective to give T-20, a new type of anti-HIV drug, with a combination of other anti-HIV drugs. The other anti-HIV drugs used are abacavir (ABC), amprenavir (APV), ritonavir (RTV), and efavirenz (EFV). Three different doses of T-20 are tested. 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, Ritonavir and Abacavir sulfate
- How many people
- 68 participants
- Where
- 20 sitesUnited States
- Study dates
- May 1999to 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
- Patients may be eligible for this study if they:
- Are HIV-positive.
- Have an HIV level (viral load) between 400 and 100,000 copies/ml at the screening visit.
- Have taken at least 1 PI (protease inhibitor) for at least 16 weeks, and have had no interruptions in their most recent PI-containing anti-HIV drug regimen.
- Are at least 18 years old.
- Agree to abstinence or use of 2 effective methods of birth control, including a barrier method, during the study.
Who cannot join
- Patients will not be eligible for this study if they:
- Have ever taken an NNRTI (nonnucleoside reverse transcriptase inhibitor).
- Have an opportunistic (HIV-related) infection.
- Have had an unexplained fever of at least 38.5 C for 7 days in a row within 30 days prior to screening.
- Have had diarrhea lasting at least 15 days within 30 days prior to screening.
- Have ever taken abacavir, amprenavir, or efavirenz (ABC, APV, or EFV).
Show all 17Show fewer
- Have certain genetic characteristics (drug resistance mutations) that could change the way a drug acts in the body.
- Are allergic to any of the study medications.
- Have a tumor other than certain skin or cervical cancers.
- Are on chemotherapy that cannot be discontinued during the study.
- Are taking an investigational drug within 30 days prior to screening.
- Have ever received an HIV vaccine.
- Are taking certain medications.
- Abuse drugs or alcohol.
- Have hemophilia or another blood clotting disorder.
- Have had an organ transplant.
- Are pregnant or breast-feeding.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
IDC Research Initiative
Altamonte Springs, Florida, 32701
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
Central Texas Clinical Research
Austin, Texas, 78705
Johns Hopkins Hosp
Baltimore, Maryland, 21287
Pacific Oaks Research
Beverly Hills, California, 90211
Trimeris Inc
Durham, North Carolina, 27707
Gary Richmond MD
Fort Lauderdale, Florida, 33316
UCLA Care Ctr
Los Angeles, California, 90095
New York Univ Med Ctr
New York, New York, 10016
ViRx Inc
Palm Springs, California, 92262
Donald Northfelt
Palm Springs, California, 92270
Pennsylvania Oncology and Hematology Associates
Philadelphia, Pennsylvania, 19106
Philadelphia FIGHT
Philadelphia, Pennsylvania, 19107
Univ of Pittsburgh
Pittsburgh, Pennsylvania, 15261
UCSD
San Diego, California, 92103
ViRx Inc
San Francisco, California, 94109
Quest Clinical Research
San Francisco, California, 94115
Washington Univ School of Medicine
St Louis, Missouri, 63110
Associates of Med and Mental Health
Tulsa, Oklahoma, 74114
Dupont Circle Physicians Group
Washington D.C., District of Columbia, 200091104
About this study
Official title: A Controlled Phase 2 Trial Assessing Three Doses of T-20 in Combination With Abacavir, Amprenavir, Ritonavir, and Efavirenz in HIV-1 Infected Adults
The purpose of this study is to see if it is safe and effective to give T-20, a new type of anti-HIV drug, with a combination of other anti-HIV drugs. The other anti-HIV drugs used are abacavir (ABC), amprenavir (APV), ritonavir (RTV), and efavirenz (EFV). Three different doses of T-20 are tested.
Read the detailed description
Patients are assigned to one of four groups. Three dose groups receive a background antiretroviral regimen (ABC, APV, RTV, and EFV) and T-20, which is given at one of three doses on a twice-daily regimen. The fourth group (control) receives the background antiretroviral regimen alone. For each treatment group, 17 patients are enrolled. Treatment is administered for 16 weeks, followed by a 32-week treatment extension, and a 2-week follow-up period. The following are assessed throughout the trial: safety parameters (as measured by hematology, clinical chemistry, urinalysis, and treatment-emergent adverse events); virologic and immunologic activity; phenotypic and genotypic resistance; T-20 plasma levels; and pharmacokinetics of T-20 and oral antiretrovirals. The total study duration is 1 year.
- Conditions
- HIV Infections
- Being tested
- Enfuvirtide, Ritonavir, Abacavir sulfate, Amprenavir, Efavirenz
- Keywords
- HIV-1, Dose-Response Relationship, Drug, Drug Therapy, Combination, VX 478, Anti-HIV Agents, pentafuside, abacavir, efavirenz
- 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
RitonavirDrug
Abacavir sulfateDrug
AmprenavirDrug
EfavirenzDrug
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)
- Study startMay 1999
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.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- 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
- 68 participants
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Trimeris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002239
- Sponsor's protocol ID
- T20-206
- Other IDs
- 295B
- Status last verified
- Nov 2005
- First submitted
- 2 Nov 1999
- Last updated
- 15 Nov 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled Phase 2 Trial Assessing Three Doses of T-20 in Combination With Abacavir, Amprenavir, Ritonavir, and Efavirenz in HIV-1 Infected Adults
- ClinicalTrials.gov ID
- NCT00002239
- Acronym / sponsor ID
- T20-206
- Conditions
- HIV Infections
- Keywords
- HIV-1, Dose-Response Relationship, Drug, Drug Therapy, Combination, VX 478, Anti-HIV Agents, pentafuside, abacavir, efavirenz
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Collaborators
- Trimeris
- Study start
- May 1999
- 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, a new type of anti-HIV drug, with a combination of other anti-HIV drugs. The other anti-HIV drugs used are abacavir (ABC), amprenavir (APV), ritonavir (RTV), and efavirenz (EFV). Three different doses of T-20 are tested.
Detailed description
Patients are assigned to one of four groups. Three dose groups receive a background antiretroviral regimen (ABC, APV, RTV, and EFV) and T-20, which is given at one of three doses on a twice-daily regimen. The fourth group (control) receives the background antiretroviral regimen alone. For each treatment group, 17 patients are enrolled. Treatment is administered for 16 weeks, followed by a 32-week treatment extension, and a 2-week follow-up period. The following are assessed throughout the trial: safety parameters (as measured by hematology, clinical chemistry, urinalysis, and treatment-emergent adverse events); virologic and immunologic activity; phenotypic and genotypic resistance; T-20 plasma levels; and pharmacokinetics of T-20 and oral antiretrovirals. The total study duration is 1 year.
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 (6 listed)
- Are HIV-positive.
- Have an HIV level (viral load) between 400 and 100,000 copies/ml at the screening visit.
- Have taken at least 1 PI (protease inhibitor) for at least 16 weeks, and have had no interruptions in their most recent PI-containing anti-HIV drug regimen.
- Are at least 18 years old.
- Agree to abstinence or use of 2 effective methods of birth control, including a barrier method, during the study.
Key exclusion criteria (17 listed)
- Have ever taken an NNRTI (nonnucleoside reverse transcriptase inhibitor).
- Have an opportunistic (HIV-related) infection.
- Have had an unexplained fever of at least 38.5 C for 7 days in a row within 30 days prior to screening.
- Have had diarrhea lasting at least 15 days within 30 days prior to screening.
- Have ever taken abacavir, amprenavir, or efavirenz (ABC, APV, or EFV).
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 | – |
| Ritonavir | Drug | – |
| Abacavir sulfate | Drug | – |
| Amprenavir | Drug | – |
| Efavirenz | 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 15 Nov 2005.
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
The record lists no contact. Use the official record to reach the sponsor.
20 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, Ritonavir and Abacavir sulfate in people with HIV Infections, run by Hoffmann-La Roche at 20 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 6 inclusion and 17 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 15 Nov 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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 15 Nov 2005.