HIV InfectionsPhase 3NCT00008554
Comparison of GW433908 and Nelfinavir in HIV Patients Who Have Not Had Antiretroviral Therapy
A Phase 3 study testing Abacavir sulfate, Nelfinavir mesylate and Lamivudine in people with HIV Infections, run by Glaxo Wellcome at 23 sites in United States.
Trial summary
The purpose of this study is to compare GW433908 and nelfinavir when each is given with abacavir and lamivudine to HIV patients who have not taken antiretroviral drugs. 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, Nelfinavir mesylate and Lamivudine
- How many people
- 210 participants
- Where
- 23 sitesUnited States
- Study dates
- Nov 2000to 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients may be eligible for this study if they:
- Are at least 13 years old (consent of parent or guardian required if under 18).
- Agree to use a proven barrier method of birth control (e.g., spermicide plus condom) during the study period (hormonal birth control will not be accepted), if able to have children.
- Have received less than 4 weeks treatment with any nucleoside reverse transcriptase inhibitor (NRTI) and have never received any nonnucleoside reverse transcriptase inhibitor (NNRT) or protease inhibitor (PI).
- Have a viral load (amount of HIV in the blood) of 5,000 copies/ml or more, or have a positive result at the screening visit.
Who cannot join
- Patients will not be eligible for this study if they:
- Abuse drugs or alcohol in a way that would interfere with the study, in the opinion of the doctor. Patients stable on methadone will be considered for participation.
- Have an active/acute CDC Category C event.
- Are unable to absorb or take medicines by mouth.
- Are pregnant or breast-feeding.
- Have a serious medical condition (such as diabetes, heart problem, hepatitis) that might affect the safety of the patient.
Show all 13Show fewer
- Have had pancreatitis or hepatitis within the last 6 months.
- Have been treated with radiation or chemotherapy within 28 days before the study drug will be taken, or will have the need for these during the study.
- Have taken drugs that affect the immune system (such as corticosteroids, interleukins, interferons) or that have anti-HIV activity (such as hydroxyurea or foscarnet) within 28 days before the study drug will be taken.
- Have received HIV vaccine within 3 months before the study drug will be taken.
- Have received certain other drugs within 28 days before the study drug will be taken, or think that they will be needed during the study.
- Have received experimental treatments.
- Have allergies which might interfere with the study, in the opinion of the doctor.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Addiction Research and Treatment Corp
Brooklyn, New York, 11201
Brookdale Univ Hosp and Med Ctr
Brooklyn, New York, 112123198
SMO-USA Inc
Charlotte, North Carolina, 28211
Veterans Affairs Med Ctr of North Chicago
Chicago, Illinois, 60064
East Bay Clinical Trial Ctr
Concord, California, 94520
Advanced Clinical Trials Inc
Eugene, Oregon, 97401
Univ of Texas Med Branch
Galveston, Texas, 775550835
MacGregor Med Association
Houston, Texas, 77054
Walter Gaman
Irving, Texas, 75038
Univ of Kansas Med Ctr
Kansas City, Kansas, 661607415
Ocean View Internal Medicine
Long Beach, California, 90803
Gervais Frechette
New York, New York, 10011
Howard Grossman
New York, New York, 10011
Mount Sinai School of Medicine
New York, New York, 10029
Saint Michael's Med Ctr
Newark, New Jersey, 07102
UMDNJ - New Jersey Med School
Newark, New Jersey, 071032757
Florida ID Group
Orlando, Florida, 32801
Thomas Jefferson Univ
Philadelphia, Pennsylvania, 19107
Univ of Rochester Med Ctr
Rochester, New York, 14642
Southwest Texas Methodist Hosp
San Antonio, Texas, 78229
Hillsborough County Health Dept
Tampa, Florida, 33602
Clinical Pharmacology Services
Tampa, Florida, 33617
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
The Bronx, New York, 10461
About this study
Official title: A Phase III, Randomised, Multicenter, Parallel, Open-Label Study to Compare the Efficacy, Safety, and Tolerability of GW433908 (1400 Mg Bid) and Nelfinavir (1250 Mg Bid) Over 48 Weeks in Antiretroviral Therapy Naive HIV-1 Infected Adults
The purpose of this study is to compare GW433908 and nelfinavir when each is given with abacavir and lamivudine to HIV patients who have not taken antiretroviral drugs.
Read the detailed description
Patients are randomized in a 2:1 scheme to 1 of 2 treatment groups. Group 1 receives GW433908 plus abacavir (ABC) plus lamivudine (3TC); Group 2 receives nelfinavir (NFV) plus ABC plus 3TC. Patients undergo safety and efficacy assessments at the Screening Visit, Day 1 (Entry), and Weeks 1, 2, 4, 8, 12, 16, 20, 24, and every 8 weeks thereafter. A follow-up visit is performed 4 weeks after the permanent discontinuation of study drug. Detailed assessments for the development of lipodystrophy/fat redistribution occur at Day 1, Week 24, Week 48, and every 16 weeks thereafter. Patients have examinations and laboratory tests performed at visits.
- Conditions
- HIV Infections
- Being tested
- Abacavir sulfate, Nelfinavir mesylate, Lamivudine, GW433908
- Keywords
- HIV-1, Drug Therapy, Combination, HIV Protease Inhibitors, Lamivudine, Nelfinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents, abacavir
- 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
Nelfinavir mesylateDrug
LamivudineDrug
GW433908Drug
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 startNov 2000
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
- 210 participants
Sponsor and investigators
- Lead sponsor
- Glaxo Wellcome
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00008554
- Sponsor's protocol ID
- 316A
- Other IDs
- APV30001
- Status last verified
- Jul 2001
- First submitted
- 13 Jan 2001
- 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, Randomised, Multicenter, Parallel, Open-Label Study to Compare the Efficacy, Safety, and Tolerability of GW433908 (1400 Mg Bid) and Nelfinavir (1250 Mg Bid) Over 48 Weeks in Antiretroviral Therapy Naive HIV-1 Infected Adults
- ClinicalTrials.gov ID
- NCT00008554
- Acronym / sponsor ID
- 316A
- Conditions
- HIV Infections
- Keywords
- HIV-1, Drug Therapy, Combination, HIV Protease Inhibitors, Lamivudine, Nelfinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents, abacavir
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants
- Lead sponsor
- Glaxo WellcomeIndustry (pharma, biotech, devices)
- Study start
- Nov 2000
- 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 compare GW433908 and nelfinavir when each is given with abacavir and lamivudine to HIV patients who have not taken antiretroviral drugs.
Detailed description
Patients are randomized in a 2:1 scheme to 1 of 2 treatment groups. Group 1 receives GW433908 plus abacavir (ABC) plus lamivudine (3TC); Group 2 receives nelfinavir (NFV) plus ABC plus 3TC. Patients undergo safety and efficacy assessments at the Screening Visit, Day 1 (Entry), and Weeks 1, 2, 4, 8, 12, 16, 20, 24, and every 8 weeks thereafter. A follow-up visit is performed 4 weeks after the permanent discontinuation of study drug. Detailed assessments for the development of lipodystrophy/fat redistribution occur at Day 1, Week 24, Week 48, and every 16 weeks thereafter. Patients have examinations and laboratory tests performed at visits.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Are at least 13 years old (consent of parent or guardian required if under 18).
- Agree to use a proven barrier method of birth control (e.g., spermicide plus condom) during the study period (hormonal birth control will not be accepted), if able to have children.
- Have received less than 4 weeks treatment with any nucleoside reverse transcriptase inhibitor (NRTI) and have never received any nonnucleoside reverse transcriptase inhibitor (NNRT) or protease inhibitor (PI).
- Have a viral load (amount of HIV in the blood) of 5,000 copies/ml or more, or have a positive result at the screening visit.
Key exclusion criteria (13 listed)
- Abuse drugs or alcohol in a way that would interfere with the study, in the opinion of the doctor. Patients stable on methadone will be considered for participation.
- Have an active/acute CDC Category C event.
- Are unable to absorb or take medicines by mouth.
- Are pregnant or breast-feeding.
- Have a serious medical condition (such as diabetes, heart problem, hepatitis) that might affect the safety of the patient.
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 | – |
| Nelfinavir mesylate | Drug | – |
| Lamivudine | Drug | – |
| GW433908 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
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.
23 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 Abacavir sulfate, Nelfinavir mesylate and Lamivudine in people with HIV Infections, run by Glaxo Wellcome at 23 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 13 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: status not confirmed, 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 23 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?
Results are not available in the source record.
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.