HIV InfectionsPhase 2NCT00002213
The Safety and Effectiveness of 1592U89 Plus 141W94 Plus DMP 266 in Patients With HIV Who Developed a Resistance to Protease Inhibitors
A Phase 2 study testing Abacavir sulfate, Amprenavir and Efavirenz in people with HIV Infections, run by Glaxo Wellcome at 9 sites in United States.
Trial summary
The purpose of this study is to see if it is safe and effective to give 1592U89 plus 141W94 plus DMP 266 to patients with HIV who have developed resistance to indinavir, ritonavir, saquinavir, or nelfinavir after at least 20 weeks of protease inhibitor treatment. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Abacavir sulfate, Amprenavir and Efavirenz
- How many people
- 80 participants
- Where
- 9 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Concurrent Medication:
- Allowed:
- Hematologic supportive therapy with GM-CSF, G-CSF, or erythropoietin.
- Drugs that may interact with CYP3A4, that should be used with caution including (but not limited to):
- alprazolam, carbamazepine, codeine, cimetadine, clarithromycin, dapsone, diazepam, diltiazem, erythromycin, estrogens, fluvastatin, glucocorticoids, imipramine, itraconazole, ketoconazole, lidocaine, lovastatin, nifedipine, phenobarbital, phenytoin, quinidine, rifabutin, simvastatin, and warfarin.
- Detoxification treatment including opiate agonists (methadone, buprenorphine, etc.):
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- Patients currently receiving this treatment should be enrolled only if stable on this therapy.
- Patients must have:
- HIV-1 infection (all CDC clinical categories allowed).
- HIV-1 RNA greater than 500 copies/ml when measured on 1 occasion within 14 days of study drug administration.
- Signed, informed consent from parent or legal guardian for those patients under 18 years of age.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Malabsorption syndrome or other gastrointestinal dysfunction that may interfere with drug absorption or render the patient unable to take oral medication.
- Active AIDS-defining opportunistic infection or disease that is likely to preclude the patient from study participation.
- Serious medical conditions such as diabetes, congestive heart failure, cardiomyopathy, or other cardiac dysfunction that, in the opinion of the investigator, would compromise the safety of the patient.
- Concurrent Medication:
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- Excluded:
- Immunomodulating agents, e.g., corticosteroids, interleukins, thalidomide, anti-cytokine agents and interferons.
- Cytotoxic chemotherapeutic agents (except local treatment for Kaposi's sarcoma).
- Anti-oxidants.
- Foscarnet therapy or therapy with other agents with documented activity against HIV-1 in vitro.
- Medications that interact with 141W94:
- terfenadine, astemizole, cisapride, triazolam, midazolam, and ergotamine/dihydroergotamine-containing regimens.
- Vitamin E supplements.
- Other investigational treatments (treatments available through Treatment IND or other expanded access mechanism evaluated on an individual basis).
- Concurrent Treatment:
- Excluded:
- Anticipated need for radiation therapy (with the exception of local treatment for Kaposi's sarcoma).
- Patients with the following symptoms and conditions are excluded:
- History of clinically relevant hepatitis within the previous six months.
- History of lymphoma.
- Prior Medication:
- Excluded:
- Cytotoxic chemotherapeutic agents within 30 days of study drug administration or an anticipated need for such treatment within the next 48 weeks (with exception of local treatment for Kaposi's sarcoma).
- Investigational HIV-1 vaccine trial and receipt of a dose of vaccine within the past 3 months.
- Immunomodulating agents such as systemic corticosteroids, interleukins, or interferons within 30 days of study drug administration.
- Exposure to the investigational agents 1592U89, 141W94, or DMP 266 (Sustiva).
- Prior Treatment:
- Excluded:
- Radiation therapy.
- Required:
- Treatment with at least 1 of the following protease inhibitors (PIs) for a minimum of 20 weeks prior to screening:
- indinavir, ritonavir, saquinavir, and/or nelfinavir.
- Treatment with the same combination of PIs for the most recent 12 weeks and up through entry on study (Day 1).
- Active alcohol or illicit drug use that is likely to interfere with dosing schedule compliance and protocol evaluations.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
East Bay AIDS Ctr
Berkeley, California, 94705
Niaid / Nih
Bethesda, Maryland, 20892
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, 02215
Univ of North Carolina Chapel Hill
Chapel Hill, North Carolina, 27499
Northwestern Univ Med School AIDS Treatment Unit
Chicago, Illinois, 60611
Univ Int Med Assoc Inc / Holmes Hosp / U of Cincinnati
Cincinnati, Ohio, 45267
Kraus Med Partners
Los Angeles, California, 90036
Saint Vincents Hosp / AIDS Ctr / 4th Floor
New York, New York, 10011
The Miriam Hosp
Providence, Rhode Island, 02906
About this study
Official title: A Phase II Study Evaluating the Safety and Antiviral Activity of Combination Therapy With 1592U89, 141W94 and DMP 266 in HIV-1 Infected Subjects With Detectable HIV-1 Plasma RNA Despite Treatment With a Protease Inhibitor Containing Regimen
The purpose of this study is to see if it is safe and effective to give 1592U89 plus 141W94 plus DMP 266 to patients with HIV who have developed resistance to indinavir, ritonavir, saquinavir, or nelfinavir after at least 20 weeks of protease inhibitor treatment. This study also examines how long this combination therapy is effective before patients develop resistance to it.
Read the detailed description
This is a multicenter, open-label study. A total of 80 patients are treated on this study and include:
At least 30 patients with a viral burden of 500 - 40,000 copies/ml. At least 30 patients with a viral burden greater than 40,000 copies/ml. At least 20 patients with less than 1 year total prior treatment with nucleoside reverse transcriptase inhibitors (NRTIs).
All patients receive self-administered, combination antiretroviral therapy for 48 weeks, as follows:
1592U89 plus 141W94 plus DMP 266.
- Conditions
- HIV Infections
- Being tested
- Abacavir sulfate, Amprenavir, Efavirenz
- Keywords
- HIV-1, Drug Therapy, Combination, Antiviral Agents, HIV Protease Inhibitors, RNA, Viral, VX 478, Anti-HIV Agents, 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.
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)
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
- 80 participants
Sponsor and investigators
- Lead sponsor
- Glaxo Wellcome
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002213
- Sponsor's protocol ID
- 264F
- Other IDs
- CNAA2007
- Status last verified
- Mar 1998
- 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 Study Evaluating the Safety and Antiviral Activity of Combination Therapy With 1592U89, 141W94 and DMP 266 in HIV-1 Infected Subjects With Detectable HIV-1 Plasma RNA Despite Treatment With a Protease Inhibitor Containing Regimen
- ClinicalTrials.gov ID
- NCT00002213
- Acronym / sponsor ID
- 264F
- Conditions
- HIV Infections
- Keywords
- HIV-1, Drug Therapy, Combination, Antiviral Agents, HIV Protease Inhibitors, RNA, Viral, VX 478, Anti-HIV Agents, abacavir
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants
- Lead sponsor
- Glaxo WellcomeIndustry (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 1592U89 plus 141W94 plus DMP 266 to patients with HIV who have developed resistance to indinavir, ritonavir, saquinavir, or nelfinavir after at least 20 weeks of protease inhibitor treatment. This study also examines how long this combination therapy is effective before patients develop resistance to it.
Detailed description
This is a multicenter, open-label study. A total of 80 patients are treated on this study and include:
At least 30 patients with a viral burden of 500 - 40,000 copies/ml. At least 30 patients with a viral burden greater than 40,000 copies/ml. At least 20 patients with less than 1 year total prior treatment with nucleoside reverse transcriptase inhibitors (NRTIs).
All patients receive self-administered, combination antiretroviral therapy for 48 weeks, as follows:
1592U89 plus 141W94 plus DMP 266.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Hematologic supportive therapy with GM-CSF, G-CSF, or erythropoietin.
- Drugs that may interact with CYP3A4, that should be used with caution including (but not limited to):
- alprazolam, carbamazepine, codeine, cimetadine, clarithromycin, dapsone, diazepam, diltiazem, erythromycin, estrogens, fluvastatin, glucocorticoids, imipramine, itraconazole, ketoconazole, lidocaine, lovastatin, nifedipine, phenobarbital, phenytoin, quinidine, rifabutin, simvastatin, and warfarin.
- Detoxification treatment including opiate agonists (methadone, buprenorphine, etc.):
- Patients currently receiving this treatment should be enrolled only if stable on this therapy.
Key exclusion criteria (35 listed)
- Malabsorption syndrome or other gastrointestinal dysfunction that may interfere with drug absorption or render the patient unable to take oral medication.
- Active AIDS-defining opportunistic infection or disease that is likely to preclude the patient from study participation.
- Serious medical conditions such as diabetes, congestive heart failure, cardiomyopathy, or other cardiac dysfunction that, in the opinion of the investigator, would compromise the safety of the patient.
- Immunomodulating agents, e.g., corticosteroids, interleukins, thalidomide, anti-cytokine agents and interferons.
- Cytotoxic chemotherapeutic agents (except local treatment for Kaposi's sarcoma).
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 |
|---|---|---|
| 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 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.
The record lists no contact. Use the official record to reach the sponsor.
9 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 Abacavir sulfate, Amprenavir and Efavirenz in people with HIV Infections, run by Glaxo Wellcome at 9 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 11 inclusion and 35 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 9 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.