HIV InfectionsPhase 1NCT00000901
Safety and Effectiveness of Giving Indinavir Plus Stavudine Plus Lamivudine to HIV-Infected Children
A Phase 1 study testing Indinavir sulfate, Lamivudine and Stavudine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 19 sites in 2 countries.
Trial summary
The purpose of this study is to see if it is safe and effective to give an anti-HIV drug combination of indinavir (IDV) plus stavudine (d4T) plus lamivudine (3TC) to HIV-infected children. IDV will be given either as a powder mixed into applesauce or as capsules given on an empty stomach. Read more about this study
- Who is it for?
- Ages 3 to 15 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Indinavir sulfate, Lamivudine and Stavudine
- How many people
- 24 participants
- Where
- 19 sitesin 2 countries
- Study dates
- Start not givento Oct 2000
- Phase
- Phase 1
- 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 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Your child may be eligible for this study if he/she:
- Is 3 - 15 years old and has consent of a parent or legal guardian who is able to return with the child for follow-up visits.
- Is HIV-positive.
- Is generally healthy.
- Is able to swallow medication in capsule form.
- Has never taken d4T or has never taken 3TC.
- Agrees to use barrier methods of birth control (such as condoms) during the study. The pill is not allowed during the study.
Who cannot join
- Your child will not be eligible for this study if he/she:
- Has a serious infection at the time of study entry.
- Has a history of severe diarrhea.
- Is unable to take any of the medications in this study for any reason.
- Has a history of certain serious illnesses.
- Has taken any protease inhibitors (PIs).
Show all 9Show fewer
- Has taken any non-nucleoside reverse transcriptase inhibitors (NNRTIs), such as efavirenz (EFV), within 2 weeks prior to study entry.
- Has taken certain medications.
- Is pregnant or breast-feeding.
Trial locations and contacts
19 sites in 2 countries.
19 sites in 2 countries
United States18 sites
Children's Hosp of Boston
Boston, Massachusetts, 021155724
Med Univ of South Carolina
Charleston, South Carolina, 294253312
Duke Univ Med Ctr
Durham, North Carolina, 277103499
Univ of Florida Gainesville
Gainesville, Florida, 32610
North Shore Univ Hosp
Great Neck, New York, 11021
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, 32209
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, 920930672
Saint Jude Children's Research Hosp of Memphis
Memphis, Tennessee, 381052794
Univ of Miami (Pediatric)
Miami, Florida, 33161
Yale Univ Med School
New Haven, Connecticut, 06504
Schneider Children's Hosp
New Hyde Park, New York, 11040
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016
Columbia Presbyterian Med Ctr
New York, New York, 10032
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
New York, New York, 10032
Children's Hosp of Philadelphia
Philadelphia, Pennsylvania, 191044318
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, 941430105
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, 981050371
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, 13210
About this study
Official title: A Multicenter, Open-Labeled, 96-Week Study to Investigate the Safety, Pharmacokinetics, and Efficacy of Indinavir in Combination With Stavudine and Lamivudine in Pediatric Patients With HIV-1 Infection
The purpose of this study is to see if it is safe and effective to give an anti-HIV drug combination of indinavir (IDV) plus stavudine (d4T) plus lamivudine (3TC) to HIV-infected children. IDV will be given either as a powder mixed into applesauce or as capsules given on an empty stomach.
Read the detailed description
In this multicenter, open-label study patients receive a combined drug regimen of indinavir, stavudine, and lamivudine over 48 weeks. Patients are evaluated at Weeks 0, 2, 4, every 4 weeks until Week 24, and every 8 weeks thereafter until study completion. [AS PER AMENDMENT 4/27/99: The study has been extended for an additional 48 weeks for a total of 96 weeks.]
- Conditions
- HIV Infections
- Being tested
- Indinavir sulfate, Lamivudine, Stavudine
- Keywords
- Dose-Response Relationship, Drug, Drug Therapy, Combination, Stavudine, HIV Protease Inhibitors, Lamivudine, Indinavir, RNA, Viral, Reverse Transcriptase Inhibitors, Viral Load
- 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
LamivudineDrug
StavudineDrug
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 completionOct 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.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Enrolment
- 24 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- John Sleasman, Study chairRoss McKinney, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000901
- Sponsor's protocol ID
- ACTG 395
- Other IDs
- 11351
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 28 Oct 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Labeled, 96-Week Study to Investigate the Safety, Pharmacokinetics, and Efficacy of Indinavir in Combination With Stavudine and Lamivudine in Pediatric Patients With HIV-1 Infection
- ClinicalTrials.gov ID
- NCT00000901
- Acronym / sponsor ID
- ACTG 395
- Conditions
- HIV Infections
- Keywords
- Dose-Response Relationship, Drug, Drug Therapy, Combination, Stavudine, HIV Protease Inhibitors, Lamivudine, Indinavir, RNA, Viral, Reverse Transcriptase Inhibitors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- Oct 2000 (actual)
- 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 see if it is safe and effective to give an anti-HIV drug combination of indinavir (IDV) plus stavudine (d4T) plus lamivudine (3TC) to HIV-infected children. IDV will be given either as a powder mixed into applesauce or as capsules given on an empty stomach.
Detailed description
In this multicenter, open-label study patients receive a combined drug regimen of indinavir, stavudine, and lamivudine over 48 weeks. Patients are evaluated at Weeks 0, 2, 4, every 4 weeks until Week 24, and every 8 weeks thereafter until study completion. [AS PER AMENDMENT 4/27/99: The study has been extended for an additional 48 weeks for a total of 96 weeks.]
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 3 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Is 3 - 15 years old and has consent of a parent or legal guardian who is able to return with the child for follow-up visits.
- Is HIV-positive.
- Is generally healthy.
- Is able to swallow medication in capsule form.
- Has never taken d4T or has never taken 3TC.
Key exclusion criteria (9 listed)
- Has a serious infection at the time of study entry.
- Has a history of severe diarrhea.
- Is unable to take any of the medications in this study for any reason.
- Has a history of certain serious illnesses.
- Has taken any protease inhibitors (PIs).
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 | Drug | – |
| Stavudine | 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 28 Oct 2021.
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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.
John Sleasman study chair
Ross McKinney study chair
19 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Indinavir sulfate, Lamivudine and Stavudine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 19 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 7 inclusion and 9 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 28 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 28 Oct 2021.