HIV InfectionsPhase 3NCT00002436
The Safety and Effectiveness of Three Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Taken AZT
A Phase 3 study testing Lamivudine, Zidovudine and Zalcitabine in people with HIV Infections, run by Glaxo Wellcome at 22 sites in 3 countries.
Trial summary
To evaluate the safety and efficacy of low and high doses of lamivudine ( 3TC ) in combination with zidovudine ( AZT ) and zalcitabine ( dideoxycytidine; ddC ) in combination with AZT. PER 02/27/95 AMENDMENT: To evaluate the efficacy and safety of both blinded and open-label combination therapy. 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 and Zalcitabine
- How many people
- 325 participants
- Where
- 22 sitesin 3 countries
- 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 positivity.
- CD4 count 100-300 cells/mm3.
- Prior AZT therapy for 24 or more weeks and currently on AZT.
Who cannot join
- Patients with the following prior conditions are excluded:
- History of intolerance to AZT.
- History of grade 2 or worse peripheral neuropathy.
- Prior Medication:
- Excluded:
- Any prior antiretroviral therapy other than AZT.
Show all 10Show fewer
- Required:
- Concomitant AZT therapy.
- Required:
- At least 24 weeks of prior AZT.
Trial locations and contacts
22 sites in 3 countries.
22 sites in 3 countries
United States18 sites
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
Central Texas Med Foundation
Austin, Texas, 78751
Boston City Hosp / FGH-1
Boston, Massachusetts, 02118
Nalle Clinic
Charlotte, North Carolina, 28207
Chicago Ctr for Clinical Research
Chicago, Illinois, 60607
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, 75235
Nicholaos Bellos
Dallas, Texas, 75246
Duke Univ Med Ctr
Durham, North Carolina, 27710
Nassau County Med Ctr
East Meadow, New York, 11554
Milton S Hershey Med Ctr
Hershey, Pennsylvania, 17033
Houston Clinical Research Network
Houston, Texas, 77006
Combat Group
Los Angeles, California, 90028
Wisconsin Community - Based Research Consortium
Milwaukee, Wisconsin, 53202
Louisiana Cardiovascular Research Ctr
New Orleans, Louisiana, 70119
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, 10019
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, 97210
San Diego Community Research Group
San Diego, California, 92104
ViRx Inc
San Francisco, California, 94103
Canada3 sites
Montreal Gen Hosp
Montreal, Quebec
Ottawa General Hospital
Ottawa, Ontario
Toronto Hosp
Toronto, Ontario
About this study
Official title: A Randomized Lamivudine (3TC)/Dideoxycytidine (ddC) Double-Blind Multicenter Trial (With Open-Label AZT) to Evaluate the Safety and Efficacy of Low Dose 3TC Administered Concurrently With AZT Versus High Dose 3TC Administered Concurrently With AZT Versus ddC Administered Concurrently With AZT in the Treatment of HIV-1 Infected, AZT-Experienced (>= 24 Weeks) Patients With CD4 Counts of 100-300 Cells/mm3
To evaluate the safety and efficacy of low and high doses of lamivudine ( 3TC ) in combination with zidovudine ( AZT ) and zalcitabine ( dideoxycytidine; ddC ) in combination with AZT.
PER 02/27/95 AMENDMENT: To evaluate the efficacy and safety of both blinded and open-label combination therapy.
Read the detailed description
Patients are randomized to one of three treatment arms: low-dose 3TC plus AZT, high-dose 3TC plus AZT, or ddC plus AZT. Treatment continues for 32 weeks, with possible extension to 52 weeks.
PER 02/27/95 AMENDMENT: Patients may continue therapy on AZT and low-dose 3TC on an open-label basis. Open-label therapy continues with follow-up every 8 weeks until intolerable toxicity occurs or study terminates.
- Conditions
- HIV Infections
- Being tested
- Lamivudine, Zidovudine, Zalcitabine
- Keywords
- Zalcitabine, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents, Zidovudine
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LamivudineDrug
ZidovudineDrug
ZalcitabineDrug
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
- 325 participants
Sponsor and investigators
- Lead sponsor
- Glaxo Wellcome
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002436
- Sponsor's protocol ID
- 129C
- Other IDs
- NUCA 3002
- Status last verified
- May 1994
- 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 Lamivudine (3TC)/Dideoxycytidine (ddC) Double-Blind Multicenter Trial (With Open-Label AZT) to Evaluate the Safety and Efficacy of Low Dose 3TC Administered Concurrently With AZT Versus High Dose 3TC Administered Concurrently With AZT Versus ddC Administered Concurrently With AZT in the Treatment of HIV-1 Infected, AZT-Experienced (>= 24 Weeks) Patients With CD4 Counts of 100-300 Cells/mm3
- ClinicalTrials.gov ID
- NCT00002436
- Acronym / sponsor ID
- 129C
- Conditions
- HIV Infections
- Keywords
- Zalcitabine, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents, Zidovudine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 325 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 evaluate the safety and efficacy of low and high doses of lamivudine ( 3TC ) in combination with zidovudine ( AZT ) and zalcitabine ( dideoxycytidine; ddC ) in combination with AZT.
PER 02/27/95 AMENDMENT: To evaluate the efficacy and safety of both blinded and open-label combination therapy.
Detailed description
Patients are randomized to one of three treatment arms: low-dose 3TC plus AZT, high-dose 3TC plus AZT, or ddC plus AZT. Treatment continues for 32 weeks, with possible extension to 52 weeks.
PER 02/27/95 AMENDMENT: Patients may continue therapy on AZT and low-dose 3TC on an open-label basis. Open-label therapy continues with follow-up every 8 weeks until intolerable toxicity occurs or study terminates.
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 (4 listed)
- HIV positivity.
- CD4 count 100-300 cells/mm3.
- Prior AZT therapy for 24 or more weeks and currently on AZT.
Key exclusion criteria (10 listed)
- History of intolerance to AZT.
- History of grade 2 or worse peripheral neuropathy.
- Any prior antiretroviral therapy other than AZT.
- Concomitant AZT therapy.
- At least 24 weeks of prior AZT.
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 | Drug | – |
| Zidovudine | Drug | – |
| Zalcitabine | 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.
22 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lamivudine, Zidovudine and Zalcitabine in people with HIV Infections, run by Glaxo Wellcome at 22 sites in 3 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 4 inclusion and 10 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 22 sites in United States, Canada, 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.
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.