HIV InfectionsNCT00002203
A Study of Two Anti-HIV Drug Combinations
A study testing Lamivudine/Zidovudine, Lamivudine and Zidovudine in people with HIV Infections, run by Glaxo Wellcome at 7 sites in 2 countries.
Trial summary
The purpose of this study is to compare the safety and effectiveness of taking lamivudine (3TC) plus zidovudine (ZDV) plus a protease inhibitor (PI) with taking the 3TC/ZDV combination tablet (Combivir) plus a PI. This study also examines how well patients follow the dosing schedules for these drugs. 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?
- Lamivudine/Zidovudine, Lamivudine and Zidovudine
- How many people
- Not given
- Where
- 7 sitesin 2 countries
- Study dates
- Start not givento not given
- Phase
- Interventional
- 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 infection documented by a licensed antibody ELISA assay and confirmed by Western blot, positive HIV blood culture, positive HIV serum antigen, or plasma viremia.
- CD4+ cell count of at least 300 cells/mm3.
- HIV-1 RNA less than 10,000 copies/ml by Roche Amplicor PCR assay.
- CDC Category A or B Classification for HIV infection (no clinical diagnosis of AIDS).
- Compliance with dosing schedule and protocol evaluations.
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- Prior Medication:
- Required:
- 3TC at 150 mg bid, ZDV at 600 mg/day (200 mg tid or 300 mg bid), plus a marketed protease inhibitor (ritonavir, saquinavir, indinavir, or nelfinavir) at its recommended dose for at least 10 weeks.
- Allowed:
- Inhaled corticosteroids for the treatment of asthma.
Who cannot join
- Co-existing Condition:
- Patients with the following conditions or symptoms are excluded:
- Malabsorption syndromes affecting drug absorption (e.g., Crohn's disease and chronic pancreatitis).
- Enrollment in other investigational protocols.
- Concurrent Medication:
- Excluded:
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- Cytotoxic chemotherapeutic agents.
- Nonnucleoside reverse transcriptase inhibitors.
- Other investigational agents.
- Concurrent Treatment:
- Excluded:
- Radiation therapy.
- Prior Medication:
- Excluded:
- Cytotoxic chemotherapeutic and immunomodulating agents such as systemic corticosteroids, IF-2, alpha-IFN, beta-IFN, or gamma-IFN (except for inhaled corticosteroids for the treatment of asthma) within 4 weeks of study entry.
- HIV immunotherapeutic vaccine within 3 months of study entry.
- Prior Treatment:
- Excluded:
- Radiation therapy within 4 weeks of study entry.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States6 sites
Infectious Diseases Physicians Inc
Annandale, Virginia, 22003
Pacific Oaks Med Ctr
Beverly Hills, California, 90211
Univ of North Carolina Hosps
Chapel Hill, North Carolina, 27599
Carolinas Med Ctr
Charlotte, North Carolina, 28232
Tower Infectious Diseases / Med Associates Inc
Los Angeles, California, 90048
Univ of Wisconsin School of Medicine
Madison, Wisconsin, 53792
About this study
Official title: A Randomized, Multicenter Study of Epivir 150 Mg Bid, Retrovir 200 Mg Tid and a Protease Inhibitor Vs 3TC 150 Mg/ZDV 300 Mg Fixed Dose Tablet Given Bid With a Protease Inhibitor in HIV-Infected Patients
The purpose of this study is to compare the safety and effectiveness of taking lamivudine (3TC) plus zidovudine (ZDV) plus a protease inhibitor (PI) with taking the 3TC/ZDV combination tablet (Combivir) plus a PI. This study also examines how well patients follow the dosing schedules for these drugs.
Doctors believe that taking Combivir plus a PI may be as effective as taking 3TC plus ZDV plus a PI.
Read the detailed description
It is hypothesized that a fixed-dose 3TC/ZDV tablet given bid in combination with a protease inhibitor is clinically equivalent in its effect on plasma HIV-1 RNA level to a conventional regimen of 3TC, ZDV, and a protease inhibitor.
Patients are stratified according to their current protease inhibitor therapy and randomized to receive open-label therapy of 1 Combivir tablet bid (Arm II) or an equivalent dose of 3TC and ZDV (Arm I), plus their current protease inhibitor for 16 weeks.
- Conditions
- HIV Infections
- Being tested
- Lamivudine/Zidovudine, Lamivudine, Zidovudine
- Keywords
- Drug Therapy, Combination, Zidovudine, HIV Protease Inhibitors, CD4 Lymphocyte Count, CD4-CD8 Ratio, Lamivudine, Patient Compliance, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load
- Medical subject headings
- HIV Infections, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lamivudine/ZidovudineDrug
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 N/A
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
Sponsor and investigators
- Lead sponsor
- Glaxo Wellcome
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002203
- Sponsor's protocol ID
- 280A
- Other IDs
- NZTA4001
- 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 Randomized, Multicenter Study of Epivir 150 Mg Bid, Retrovir 200 Mg Tid and a Protease Inhibitor Vs 3TC 150 Mg/ZDV 300 Mg Fixed Dose Tablet Given Bid With a Protease Inhibitor in HIV-Infected Patients
- ClinicalTrials.gov ID
- NCT00002203
- Acronym / sponsor ID
- 280A
- Conditions
- HIV Infections
- Keywords
- Drug Therapy, Combination, Zidovudine, HIV Protease Inhibitors, CD4 Lymphocyte Count, CD4-CD8 Ratio, Lamivudine, Patient Compliance, Reverse Transcriptase Inhibitors
- Study type
- Interventional
- Recruitment status
- Completed
- 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 compare the safety and effectiveness of taking lamivudine (3TC) plus zidovudine (ZDV) plus a protease inhibitor (PI) with taking the 3TC/ZDV combination tablet (Combivir) plus a PI. This study also examines how well patients follow the dosing schedules for these drugs.
Doctors believe that taking Combivir plus a PI may be as effective as taking 3TC plus ZDV plus a PI.
Detailed description
It is hypothesized that a fixed-dose 3TC/ZDV tablet given bid in combination with a protease inhibitor is clinically equivalent in its effect on plasma HIV-1 RNA level to a conventional regimen of 3TC, ZDV, and a protease inhibitor.
Patients are stratified according to their current protease inhibitor therapy and randomized to receive open-label therapy of 1 Combivir tablet bid (Arm II) or an equivalent dose of 3TC and ZDV (Arm I), plus their current protease inhibitor for 16 weeks.
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 (11 listed)
- HIV infection documented by a licensed antibody ELISA assay and confirmed by Western blot, positive HIV blood culture, positive HIV serum antigen, or plasma viremia.
- CD4+ cell count of at least 300 cells/mm3.
- HIV-1 RNA less than 10,000 copies/ml by Roche Amplicor PCR assay.
- CDC Category A or B Classification for HIV infection (no clinical diagnosis of AIDS).
- Compliance with dosing schedule and protocol evaluations.
Key exclusion criteria (19 listed)
- Malabsorption syndromes affecting drug absorption (e.g., Crohn's disease and chronic pancreatitis).
- Enrollment in other investigational protocols.
- Cytotoxic chemotherapeutic agents.
- Nonnucleoside reverse transcriptase inhibitors.
- Other investigational agents.
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 |
|---|---|---|
| Lamivudine/Zidovudine | 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.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lamivudine/Zidovudine, Lamivudine and Zidovudine in people with HIV Infections, run by Glaxo Wellcome at 7 sites in 2 countries.
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 19 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 7 sites in United States, Puerto Rico. 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.
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.