HIV InfectionsPhase 3NCT00002195
A Study of Retrovir and Epivir Alone or in Combination With 141W94 in HIV-Infected Patients
A Phase 3 study testing Amprenavir, Lamivudine and Zidovudine 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 add 141W94 to an anti-HIV regimen that includes retrovir plus epivir. 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?
- Amprenavir, Lamivudine and Zidovudine
- How many people
- 290 participants
- Where
- 9 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:
- HIV-positive status.
- Screening viral load >= 10,000 copies/mm3 14 days prior to entry.
- CD4+ cell counts >= 200 cells/mm3 14 days prior to entry.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Clinical diagnosis of AIDS (CDC 1993 Classification C).
- Concurrent Medication:
- Excluded:
- Terfenadine, astemizole, cisapride, triazolam, medazolam, and ergotamine/dihydroergotamine-containing regimens.
Show all 20Show fewer
- Patients with the following prior conditions are excluded:
- Clinically relevant hepatitis in the previous 6 months.
- Prior Medication:
- Excluded:
- Greater than 4 weeks of any nucleoside antiretroviral therapy.
- Previous therapy with an HIV protease inhibitor.
- Cytotoxic chemotherapeutic agents within 4 weeks prior to entry.
- Immunomodulating agents within 3 months prior to entry.
- Prior Treatment:
- Excluded:
- Radiotherapy within 4 weeks prior to entry.
- Risk Behavior:
- Excluded:
- Current alcohol or illicit drug use that may interfere with the patient's ability to comply with the dosing schedule or protocol evaluations.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Pacific Oaks Research
Beverly Hills, California, 90211
Community Research Initiative of New England
Brookline, Massachusetts, 02445
Chicago Ctr for Clinical Research
Chicago, Illinois, 60610
Community Research Initiative of South Florida
Coral Gables, Florida, 33146
Community Research Initiative of Central Florida
Maitland, Florida, 32751
Methodist Hosp
Memphis, Tennessee, 38104
Univ of Miami School of Medicine
Miami, Florida, 33136
Saint Vincent's AIDS Ctr
New York, New York, 10011
Dr Bruce Rashbaum
Washington D.C., District of Columbia, 20037
About this study
Official title: A Phase III Trial to Evaluate the Safety and Antiviral Efficacy of 141W94 in Combination With Retrovir and Epivir Compared to Retrovir and Epivir Alone in Patients With HIV Infection.
The purpose of this study is to see if it is safe and effective to add 141W94 to an anti-HIV regimen that includes retrovir plus epivir.
Read the detailed description
This is a double-blind, placebo-controlled, two-arm study comparing treatment with a triple regimen consisting of 141W94, retrovir, and epivir and a double regimen consisting of retrovir and epivir.
- Conditions
- HIV Infections
- Being tested
- Amprenavir, Lamivudine, Zidovudine
- Keywords
- Drug Therapy, Combination, Zidovudine, HIV Protease Inhibitors, Lamivudine, 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.
AmprenavirDrug
LamivudineDrug
ZidovudineDrug
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
- Intervention model
- Parallel groups
- Enrolment
- 290 participants
Sponsor and investigators
- Lead sponsor
- Glaxo Wellcome
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002195
- Sponsor's protocol ID
- 264D
- Other IDs
- PROA3001
- 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 Evaluate the Safety and Antiviral Efficacy of 141W94 in Combination With Retrovir and Epivir Compared to Retrovir and Epivir Alone in Patients With HIV Infection.
- ClinicalTrials.gov ID
- NCT00002195
- Acronym / sponsor ID
- 264D
- Conditions
- HIV Infections
- Keywords
- Drug Therapy, Combination, Zidovudine, HIV Protease Inhibitors, Lamivudine, VX 478, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 290 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 add 141W94 to an anti-HIV regimen that includes retrovir plus epivir.
Detailed description
This is a double-blind, placebo-controlled, two-arm study comparing treatment with a triple regimen consisting of 141W94, retrovir, and epivir and a double regimen consisting of retrovir and epivir.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- HIV-positive status.
- Screening viral load >= 10,000 copies/mm3 14 days prior to entry.
- CD4+ cell counts >= 200 cells/mm3 14 days prior to entry.
Key exclusion criteria (20 listed)
- Clinical diagnosis of AIDS (CDC 1993 Classification C).
- Terfenadine, astemizole, cisapride, triazolam, medazolam, and ergotamine/dihydroergotamine-containing regimens.
- Clinically relevant hepatitis in the previous 6 months.
- Greater than 4 weeks of any nucleoside antiretroviral therapy.
- Previous therapy with an HIV protease inhibitor.
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 |
|---|---|---|
| Amprenavir | Drug | – |
| Lamivudine | Drug | – |
| Zidovudine | 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 3 study testing Amprenavir, Lamivudine and Zidovudine 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 4 inclusion and 20 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 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.