HIV InfectionsPhase 3NCT00002202
A Comparison of 141W94 and Indinavir in HIV-Infected Patients
A Phase 3 study testing Indinavir sulfate and Amprenavir in people with HIV Infections, run by Glaxo Wellcome at 24 sites in United States.
Trial summary
The purpose of this study is to see if 141W94 is as safe and effective as indinavir when used with nucleoside reverse transcriptase inhibitors (NRTIs) for 48 weeks. This study also examines what effect other drugs have on how the body handles 141W94. 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?
- Indinavir sulfate and Amprenavir
- How many people
- 460 participants
- Where
- 24 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 3
- 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 must have:
- Documented HIV infection.
- HIV RNA >= 400 copies/ml within 14 days prior to randomized study drug administration.
- No active AIDS-defining opportunistic infection or disease.
- Signed, informed consent from parent or legal guardian of patients less than 18 years of age.
Who cannot join
- Co-existing Condition:
- Patients with the following conditions or symptoms are excluded:
- Unlikely to complete the randomized dosing period.
- Malabsorption syndrome or other gastrointestinal dysfunction that might interfere with drug absorption or ability to take oral medications.
- Serious medical conditions (e.g., diabetes, cardiac dysfunction, hepatitis) that would compromise patient safety.
- Concurrent Medication:
Show all 32Show fewer
- Excluded:
- Cytotoxic chemotherapeutic agents (except local treatment for Kaposi's sarcoma).
- Investigational treatments (treatment through Treatment IND or expanded-access programs are evaluated individually).
- Immunomodulating agents such as systemic, high-dose corticosteroids, interleukins, or interferons.
- Terfenadine, astemizole, cisapride, triazolam, midazolam, and ergotamine/dihydroergotamine-containing regimens.
- Concurrent Treatment:
- Excluded:
- Radiation therapy (except local treatment for Kaposi's sarcoma).
- Patients with the following prior conditions are excluded:
- Clinically relevant pancreatitis or hepatitis within the last 6 months.
- Prior Medication:
- Excluded:
- Cytotoxic chemotherapeutic agents within 30 days of study drug administration (except local treatment for Kaposi's sarcoma).
- Protease inhibitor therapy.
- Dose of vaccine through an investigational HIV vaccine trial within the 3 months prior to study drug administration.
- Immunomodulating agents such as systemic, high-dose corticosteroids, interleukins, or interferons within 30 days of study drug administration.
- Prior Treatment:
- Excluded:
- Radiation therapy within 30 days prior to study drug administration (except local treatment for Kaposi's sarcoma).
- Risk Behavior:
- Excluded:
- Current alcohol or illicit drug use that may interfere with drug absorption or ability to take oral medication.
- Required:
- NRTI therapy at day of entry and up to screening.
- Required:
- >= 12 weeks of NRTI therapy.
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
East Bay AIDS Ctr
Berkeley, California, 94705
Boston Med Ctr / Evans - 556
Boston, Massachusetts, 021182393
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, 02215
The Nalle Clinic / Clinical Research Dept
Charlotte, North Carolina, 28207
Northwestern Univ Med School
Chicago, Illinois, 60611
CRI of South Florida
Coral Gables, Florida, 33146
Community Oriented Primary Care
Dallas, Texas, 75217
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
Univ of Texas Med Branch
Galveston, Texas, 775550835
Hampton Roads Med Specialists
Hampton, Virginia, 23666
Baylor College of Medicine / Dept of Medicine
Houston, Texas, 770303498
AIDS Healthcare Foundation
Los Angeles, California, 90027
Community Research Initiative of Central Florida
Maitland, Florida, 32751
Methodist Hosp
Memphis, Tennessee, 38104
Univ of Miami Dept of Medicine
Miami, Florida, 33136
Tulane Univ Med School
New Orleans, Louisiana, 70112
Community Research Initiative on AIDS
New York, New York, 10001
Harlem Hosp
New York, New York, 10027
Univ of Nebraska Med Ctr
Omaha, Nebraska, 681985400
The Research and Education Group
Portland, Oregon, 97210
Saint Francis Mem Hosp
San Francisco, California, 94109
ViRx Inc
San Francisco, California, 94109
Med College of Ohio / Division of Infectious Diseases
Toledo, Ohio, 43614
Whitman Walker Clinic Inc
Washington D.C., District of Columbia, 20009
About this study
Official title: A Phase III Trial to Compare the Safety and Antiviral Efficacy of 141W94 With Indinavir in Combination With Nucleoside Reverse Transcriptase Inhibitor (NRTI) Therapy, in NRTI-Experienced, Protease Inhibitor (PI)-Naive, HIV-1-Infected Patients.
The purpose of this study is to see if 141W94 is as safe and effective as indinavir when used with nucleoside reverse transcriptase inhibitors (NRTIs) for 48 weeks. This study also examines what effect other drugs have on how the body handles 141W94.
- Conditions
- HIV Infections
- Being tested
- Indinavir sulfate, Amprenavir
- Keywords
- HIV-1, Drug Therapy, Combination, HIV Protease Inhibitors, Indinavir, RNA, Viral, VX 478, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indinavir sulfateDrug
AmprenavirDrug
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 3
- Primary purpose
- Treatment
- Enrolment
- 460 participants
Sponsor and investigators
- Lead sponsor
- Glaxo Wellcome
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002202
- Sponsor's protocol ID
- 264E
- Other IDs
- PROA/B3006
- Status last verified
- Nov 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 III Trial to Compare the Safety and Antiviral Efficacy of 141W94 With Indinavir in Combination With Nucleoside Reverse Transcriptase Inhibitor (NRTI) Therapy, in NRTI-Experienced, Protease Inhibitor (PI)-Naive, HIV-1-Infected Patients.
- ClinicalTrials.gov ID
- NCT00002202
- Acronym / sponsor ID
- 264E
- Conditions
- HIV Infections
- Keywords
- HIV-1, Drug Therapy, Combination, HIV Protease Inhibitors, Indinavir, RNA, Viral, VX 478, Reverse Transcriptase Inhibitors, Anti-HIV Agents
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 460 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 141W94 is as safe and effective as indinavir when used with nucleoside reverse transcriptase inhibitors (NRTIs) for 48 weeks. This study also examines what effect other drugs have on how the body handles 141W94.
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 (5 listed)
- Documented HIV infection.
- HIV RNA >= 400 copies/ml within 14 days prior to randomized study drug administration.
- No active AIDS-defining opportunistic infection or disease.
- Signed, informed consent from parent or legal guardian of patients less than 18 years of age.
Key exclusion criteria (32 listed)
- Unlikely to complete the randomized dosing period.
- Malabsorption syndrome or other gastrointestinal dysfunction that might interfere with drug absorption or ability to take oral medications.
- Serious medical conditions (e.g., diabetes, cardiac dysfunction, hepatitis) that would compromise patient safety.
- Cytotoxic chemotherapeutic agents (except local treatment for Kaposi's sarcoma).
- Investigational treatments (treatment through Treatment IND or expanded-access programs are evaluated individually).
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 |
|---|---|---|
| Indinavir sulfate | Drug | – |
| Amprenavir | 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.
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Indinavir sulfate and Amprenavir in people with HIV Infections, run by Glaxo Wellcome at 24 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 5 inclusion and 32 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 24 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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.