HIV InfectionsPhase 3NCT00002199
A Phase III Randomized Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of 3TC/ZDV/1592U89 and 3TC/ZDV/IDV in HIV-1 Infected Antiretroviral Therapy-Naive Subjects.
A Phase 3 study testing Indinavir sulfate, Lamivudine/Zidovudine and Abacavir sulfate in people with HIV Infections, run by Glaxo Wellcome at 1 site in United States.
Trial summary
To compare the safety, tolerance, early antiviral activity, and durability of antiviral response of the lamivudine (3TC)/zidovudine (ZDV)/1592U89 arm versus the 3TC/ZDV/indinavir (IDV) arm. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Indinavir sulfate, Lamivudine/Zidovudine and Abacavir sulfate
- How many people
- 550 participants
- Where
- 1 siteUnited 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Concurrent Medication:
- Allowed:
- GM-CSF, G-CSF, and erythropoietin.
- Concurrent Treatment:
- Allowed:
- Local treatment for Kaposi's sarcoma.
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- Patients must have:
- HIV-1 infection documented by a licensed HIV-1 antibody ELISA and confirmed by Western blot detection of HIV-1 antibody or positive HIV-1 blood culture.
- CD4+ cell count >= 100 cells/mm3 within 14 days prior to study drug administration.
- HIV-1 RNA >= 10,000 copies/ml within 14 days prior to study drug administration.
- No active diagnosis of AIDS according to the 1993 Centers for Disease Control (CDC) AIDS surveillance definition (excluding CD4+ cell counts < 200 cells/mm3).
- Signed, informed consent from parent or legal guardian for patients under 18 years of age.
Who cannot join
- Co-existing Condition:
- Patients with the following conditions or symptoms are excluded:
- Malabsorption syndrome or other gastrointestinal dysfunction that may interfere with drug absorption.
- Serious medical conditions such as diabetes, congestive heart failure, cardiomyopathy, or other cardiac dysfunction that would compromise the safety of the patient.
- Concurrent Medication:
- Excluded:
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- Cytotoxic chemotherapeutic agents.
- Agents with documented anti-HIV-1 activity in vitro.
- Foscarnet.
- Immunomodulating agents such as systemic corticosteroids, interleukins, thalidomide, or interferons.
- Terfenadine, astemizole, cisapride, triazolam, midazolam, and ergotamine/dihydroergotamine.
- Concurrent Treatment:
- Excluded:
- Radiation therapy.
- Other investigational treatments. NOTE:
- Treatments available through treatment IND or other expanded access programs are the exception and evaluated individually.
- Patients with the following prior conditions are excluded:
- History of relevant pancreatitis or hepatitis in the last 6 months.
- Prior Medication:
- Excluded:
- Cytotoxic chemotherapeutic agents within 30 days of study drug administration.
- Prior antiretroviral therapy.
- HIV vaccine dose within 90 days of study drug administration.
- Immunomodulating agents such as systemic corticosteroids, interleukins, or interferons within 30 days of study entry.
- Prior Treatment:
- Excluded:
- Radiation therapy within 30 days of study drug administration.
- Current alcohol or illicit drug use that may interfere with patient compliance.
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, 02215
About this study
To compare the safety, tolerance, early antiviral activity, and durability of antiviral response of the lamivudine (3TC)/zidovudine (ZDV)/1592U89 arm versus the 3TC/ZDV/indinavir (IDV) arm. To determine the effect of the two arms on clinical efficacy as determined by the occurrence of new CDC, defined class B/C events, survival, medical resource utilization, and the development of plasma viral genotypic and phenotypic resistance.
Read the detailed description
In this international study, 550 patients are randomized (225 per arm) to receive Combivir in combination with 1592U89 or indinavir. If after 16 weeks (and every 8 weeks thereafter until week 48) a patient has HIV-1 RNA >= 400 copies/ml (by PCR on two occasions >= 1 week and < 4 weeks apart), the patient has the option to switch to open-label therapy consisting of indinavir, 1592U89, and Combivir.
- Conditions
- HIV Infections
- Being tested
- Indinavir sulfate, Lamivudine/Zidovudine, Abacavir sulfate
- Keywords
- HIV-1, Drug Therapy, Combination, Zidovudine, Drug Resistance, Microbial, HIV Protease Inhibitors, Lamivudine, Indinavir, Genotype, Phenotype, 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.
Indinavir sulfateDrug
Lamivudine/ZidovudineDrug
Abacavir sulfateDrug
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 550 participants
Sponsor and investigators
- Lead sponsor
- Glaxo Wellcome
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002199
- Sponsor's protocol ID
- 238K
- Other IDs
- CNAA/B3005
- Status last verified
- Nov 1998
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Staszewski S, Keiser P, Montaner J, Raffi F, Gathe J, Brotas V, Hicks C, Hammer SM, Cooper D, Johnson M, Tortell S, Cutrell A, Thorborn D, Isaacs R, Hetherington S, Steel H, Spreen W; CNAAB3005 International Study Team. Abacavir-lamivudine-zidovudine vs indinavir-lamivudine-zidovudine in antiretroviral-naive HIV-infected adults: A randomized equivalence trial. JAMA. 2001 Mar 7;285(9):1155-63. doi: 10.1001/jama.285.9.1155.
PubMed 11231744
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 Randomized Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of 3TC/ZDV/1592U89 and 3TC/ZDV/IDV in HIV-1 Infected Antiretroviral Therapy-Naive Subjects.
- ClinicalTrials.gov ID
- NCT00002199
- Acronym / sponsor ID
- 238K
- Conditions
- HIV Infections
- Keywords
- HIV-1, Drug Therapy, Combination, Zidovudine, Drug Resistance, Microbial, HIV Protease Inhibitors, Lamivudine, Indinavir, Genotype
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 550 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.
To compare the safety, tolerance, early antiviral activity, and durability of antiviral response of the lamivudine (3TC)/zidovudine (ZDV)/1592U89 arm versus the 3TC/ZDV/indinavir (IDV) arm. To determine the effect of the two arms on clinical efficacy as determined by the occurrence of new CDC, defined class B/C events, survival, medical resource utilization, and the development of plasma viral genotypic and phenotypic resistance.
Detailed description
In this international study, 550 patients are randomized (225 per arm) to receive Combivir in combination with 1592U89 or indinavir. If after 16 weeks (and every 8 weeks thereafter until week 48) a patient has HIV-1 RNA >= 400 copies/ml (by PCR on two occasions >= 1 week and < 4 weeks apart), the patient has the option to switch to open-label therapy consisting of indinavir, 1592U89, and Combivir.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- GM-CSF, G-CSF, and erythropoietin.
- Local treatment for Kaposi's sarcoma.
- HIV-1 infection documented by a licensed HIV-1 antibody ELISA and confirmed by Western blot detection of HIV-1 antibody or positive HIV-1 blood culture.
- CD4+ cell count >= 100 cells/mm3 within 14 days prior to study drug administration.
- HIV-1 RNA >= 10,000 copies/ml within 14 days prior to study drug administration.
Key exclusion criteria (28 listed)
- Malabsorption syndrome or other gastrointestinal dysfunction that may interfere with drug absorption.
- Serious medical conditions such as diabetes, congestive heart failure, cardiomyopathy, or other cardiac dysfunction that would compromise the safety of the patient.
- Cytotoxic chemotherapeutic agents.
- Agents with documented anti-HIV-1 activity in vitro.
- Foscarnet.
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 | – |
| Lamivudine/Zidovudine | Drug | – |
| Abacavir sulfate | 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.
- Background: PubMed 11231744Staszewski S, Keiser P, Montaner J, Raffi F, Gathe J, Brotas V, Hicks C, Hammer SM, Cooper D, Johnson M, Tortell S, Cutrell A, Thorborn D, Isaacs R, Hetherington S, Steel H, Spreen W; CNAAB3005 International Study Team. Abacavir-lamivudine-zidovudine vs indinavir-lamivudine-zidovudine in antiretroviral-naive HIV-infected adults: A randomized equivalence trial. JAMA. 2001 Mar 7;285(9):1155-63. doi: 10.1001/jama.285.9.1155.
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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.
1 site 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, Lamivudine/Zidovudine and Abacavir sulfate in people with HIV Infections, run by Glaxo Wellcome at 1 site 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 12 inclusion and 28 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 1 site 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?
On the ClinicalTrials.gov record for NCT00002199, which also lists 1 linked publication.
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; AzTrials last refreshed its copy on 27 Oct 2026.