HIV InfectionsPhase 3NCT00002391
The Safety and Effectiveness of Zidovudine Plus Lamivudine, Used With and Without 1592U89, in HIV-1 Infected Children Who Have Taken Anti-HIV-1 Drugs
A Phase 3 study testing Abacavir sulfate, Lamivudine and Zidovudine in people with HIV Infections, run by Glaxo Wellcome at 30 sites in United States.
Trial summary
To compare the safety, tolerance, durability of the viral load response and the antiviral activity of the 1592U89/zidovudine(ZDV)/lamivudine (3TC) regimen vs. ZDV/3TC regimen. To determine the clinical efficacy of the two regimens as measured survival, disease progression, weight growth velocity, and… Read more about this study
- Who is it for?
- Ages 3 months to 12 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Abacavir sulfate, Lamivudine and Zidovudine
- How many people
- Not given
- Where
- 30 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 3 months to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Concurrent Medication:
- Allowed:
- Intravenous immunoglobulin G, erythropoietin, G-CSF and GM-CSF.
- Opportunistic infection prophylaxis.
- Patients must have:
- HIV-1 infection documented by:
Show all 15Show fewer
- < 18 months of age:
- one positive viral test culture and one other positive viral test (culture, PCR, p24 antigen, or Immune Complex Dissociation p24 antigen) on two different specimens.
- >= 18 months of age:
- two positive viral tests as stated above, one or both of which may be determined by a federally documented ELISA and confirmed by Western blot or Indirect Fluorescent Antibody test.
- Any of the CDC Categories:
- 1, 2, 3, and N, A, B, and C of the 1994 Revised Classification System for HIV Infection in Children Less than 13 Years of Age.
- CD4+ count >= 15% within 14 days prior to study drug administration.
- No active or ongoing AIDS-defining opportunistic infection that precludes absorption of study drug or observation of a study parameter.
- 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:
- Serious bacterial infection that precludes absorption of study drug or observation of a study parameter.
- Documented hypersensitivity to a nucleoside analog.
- Co-enrollment in certain opportunistic infection protocols is not exclusionary if approval is obtained.
- Malignancy.
Show all 31Show fewer
- Life-threatening infection or other chronic disease that may compromise patient safety.
- Grade 3/4 clinical or laboratory toxicity or current grade 2 or higher pancreatic amylase or lipase toxicity as defined by the ACTG Toxicity Tables within 14 days prior to study entry.
- Concurrent Medication:
- Excluded:
- Other anti-HIV therapy.
- Probenecid.
- Biologic response modifier (unless listed under included concurrent medication) and megestrol acetate.
- Human growth hormone.
- Immunomodulators and cytotoxic chemotherapeutic agents.
- Systemic corticosteroids > 14 days without approval.
- Investigational agents.
- Concurrent Treatment:
- Excluded:
- Radiation therapy.
- Patients with the following prior conditions are excluded:
- History of clinically relevant pancreatitis or hepatitis within the past 6 months.
- Participation in a vaccine trial.
- Prior Medication:
- Excluded:
- Protease inhibitor therapy within 2 weeks prior to randomization.
- Interleukins or interferons within 30 days prior to study drug administration.
- Investigational drugs within 14 days prior to randomization.
- HIV vaccine dose within past 30 days.
- Required:
- > 12 weeks prior antiretroviral therapy and unchanged therapy 12 weeks prior to screening.
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
United States30 sites
Univ Alabama - Birmingham / Dept of Pediatrics / UAB Station
Birmingham, Alabama, 35294
PACT Program
Buffalo, New York, 14222
Univ of North Carolina / Pediatric Infectious Diseases
Chapel Hill, North Carolina, 27514
Med Univ of South Carolina
Charleston, South Carolina, 294253312
Mt Sinai Hosp Med Ctr / Dept of Pediatrics
Chicago, Illinois, 60608
Children's Med Ctr of Dallas / ARMS Clinic
Dallas, Texas, 75235
The Children's Med Ctr / Division of Infectious Dis
Dayton, Ohio, 454041815
Duke Univ Med Ctr / Pediatrics Dept / Infec Dis
Durham, North Carolina, 27710
Children's Diagnostic Treatment Ctr
Fort Lauderdale, Florida, 33301
Cook's Ft Worth Children Med Ctr / Pediatric Inf Dis
Fort Worth, Texas, 76104
Univ of Florida - Gainesville / Infectious Dis & Immun
Gainesville, Florida, 326100296
North Shore Univ Hosp / Pediatric Immunology
Great Neck, New York, 11021
Children's Hosp Los Angeles
Los Angeles, California, 90027
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
Univ of Miami / Fox Cancer Research Ctr
Miami, Florida, 33136
Univ of Minnesota Med School
Minneapolis, Minnesota, 55455
Schneider Children's Hosp
New Hyde Park, New York, 11040
Tulane Univ Med School
New Orleans, Louisiana, 70112
New York Hosp - Cornell / Program for Children with AIDS
New York, New York, 10021
St Luke's - Roosevelt Hosp Ctr
New York, New York, 10025
UMDNJ / Division of Allergy Immunology & Infectious Diseases
Newark, New Jersey, 07103
Eastern VA Med Sch / Children's Hosp of the King's Daughters
Norfolk, Virginia, 23507
Arnold Palmer Hosp for Women and Children
Orlando, Florida, 32806
Pediatric Special Immunology Clinic / HRS / PBC PHU
Riviera Beach, Florida, 33404
Univ of Texas Health Sciences Ctr
San Antonio, Texas, 78284
Univ of South Florida All Children's Hosp
St. Petersburg, Florida, 33701
SUNY Health Ctr at Stony Brook / Pediatric Infectious Dis
Stony Brook, New York, 117948111
SUNY Health Sciences Ctr at Syracuse / Dept of Pediatrics
Syracuse, New York, 13210
Dr Patricia Emmanuel
Tampa, Florida, 33606
Bronx Lebanon Hosp Ctr / Dept of Pediatrics
The Bronx, New York, 10457
About this study
Official title: A Double-Blind, Randomized, Multicenter Trial to Evaluate the Safety and Efficacy of the Combination of 1592U89/Zidovudine (ZDV)/Lamivudine (3TC) Versus the Combination of Zidovudine (ZDV)/Lamivudine (3TC) in HIV-1 Therapy-Experienced Pediatric Patients.
To compare the safety, tolerance, durability of the viral load response and the antiviral activity of the 1592U89/zidovudine(ZDV)/lamivudine (3TC) regimen vs. ZDV/3TC regimen. To determine the clinical efficacy of the two regimens as measured survival, disease progression, weight growth velocity, and neuropsychological or neurological changes. To assess the development of viral resistance and relative pharmacokinetics associated with each regimen.
Read the detailed description
Patients are randomized to receive blinded treatment with ZDV/3TC alone or in combination with 1592U89, orally for 16 weeks. If after the 16-week period certain criteria are met, patients may have the option to switch to open-label treatment for the remainder of the study period.
- Conditions
- HIV Infections
- Being tested
- Abacavir sulfate, Lamivudine, Zidovudine
- Keywords
- HIV-1, Drug Therapy, Combination, Zidovudine, Lamivudine, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load, Child Development, 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
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
Sponsor and investigators
- Lead sponsor
- Glaxo Wellcome
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002391
- Sponsor's protocol ID
- 238L
- Other IDs
- CNAA3006
- 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 Double-Blind, Randomized, Multicenter Trial to Evaluate the Safety and Efficacy of the Combination of 1592U89/Zidovudine (ZDV)/Lamivudine (3TC) Versus the Combination of Zidovudine (ZDV)/Lamivudine (3TC) in HIV-1 Therapy-Experienced Pediatric Patients.
- ClinicalTrials.gov ID
- NCT00002391
- Acronym / sponsor ID
- 238L
- Conditions
- HIV Infections
- Keywords
- HIV-1, Drug Therapy, Combination, Zidovudine, Lamivudine, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load, Child Development
- Phase
- Phase 3
- 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.
To compare the safety, tolerance, durability of the viral load response and the antiviral activity of the 1592U89/zidovudine(ZDV)/lamivudine (3TC) regimen vs. ZDV/3TC regimen. To determine the clinical efficacy of the two regimens as measured survival, disease progression, weight growth velocity, and neuropsychological or neurological changes. To assess the development of viral resistance and relative pharmacokinetics associated with each regimen.
Detailed description
Patients are randomized to receive blinded treatment with ZDV/3TC alone or in combination with 1592U89, orally for 16 weeks. If after the 16-week period certain criteria are met, patients may have the option to switch to open-label treatment for the remainder of the study period.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 3 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (15 listed)
- Intravenous immunoglobulin G, erythropoietin, G-CSF and GM-CSF.
- Opportunistic infection prophylaxis.
- HIV-1 infection documented by:
- one positive viral test culture and one other positive viral test (culture, PCR, p24 antigen, or Immune Complex Dissociation p24 antigen) on two different specimens.
- two positive viral tests as stated above, one or both of which may be determined by a federally documented ELISA and confirmed by Western blot or Indirect Fluorescent Antibody test.
Key exclusion criteria (31 listed)
- Serious bacterial infection that precludes absorption of study drug or observation of a study parameter.
- Documented hypersensitivity to a nucleoside analog.
- Co-enrollment in certain opportunistic infection protocols is not exclusionary if approval is obtained.
- Malignancy.
- Life-threatening infection or other chronic disease that may compromise patient safety.
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 | – |
| 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.
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
30 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, Lamivudine and Zidovudine in people with HIV Infections, run by Glaxo Wellcome at 30 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 15 inclusion and 31 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 30 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.