HIV InfectionsPhase 2NCT00002219
Safety and Effectiveness of Adding Adefovir Dipivoxil and Nelfinavir to the Anti-HIV Therapy of HIV-Infected Children
A Phase 2 study testing Nelfinavir mesylate, Levocarnitine and Adefovir dipivoxil in people with HIV Infections, run by Gilead Sciences at 7 sites in United States.
Trial summary
The purpose of this study is to see if it is safe and effective to give adefovir (a new anti-HIV drug) plus nelfinavir to HIV-infected children who are already receiving other anti-HIV medications. Read more about this study
- Who is it for?
- Ages 3 months to 16 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Nelfinavir mesylate, Levocarnitine and Adefovir dipivoxil
- How many people
- 36 participants
- Where
- 7 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 2
- 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 16 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 months to 16 years old.
- Is HIV-positive.
- Has never taken protease inhibitors or has previously taken ritonavir (RTV), saquinavir (SQV), or indinavir (IDV) and is willing to stop the medication at study entry.
- Is taking an anti-HIV drug combination that will not change during at least the 2 weeks prior to study entry.
- Agrees to use effective barrier methods of birth control, such as condoms, during the study.
- Has consent of parent or guardian.
Who cannot join
- Your child will not be eligible for this study if he/she:
- Has ever taken NFV.
- Has a history of opportunistic (AIDS-related) infection.
- Has any disease or illness that would prevent him/her from completing the study, including cancer.
- Has taken certain medications, including protease inhibitors at study entry.
- Is receiving an HIV vaccine at study entry.
- Is pregnant.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Med Univ of South Carolina
Charleston, South Carolina, 29425
Duke Univ Med Ctr / Duke South Hosp
Durham, North Carolina, 27710
North Shore Univ Hosp / Division of Immunology
Great Neck, New York, 11021
Tulane Univ Med Ctr / Dept of Pediatrics
New Orleans, Louisiana, 70112
St Lukes Roosevelt Hosp Ctr
New York, New York, 10025
All Children's Hosp
St. Petersburg, Florida, 33731
Bronx Lebanon Hosp Ctr / Dept of Pediatrics
The Bronx, New York, 10457
About this study
Official title: A Phase I/II, Open-Label, Multi-Center Study of the Pharmacokinetics, Safety, Tolerance and Activity of Two Dose Levels of Adefovir Dipivoxil (ADF) and Nelfinavir When Added to Antiretroviral Therapy for the Treatment of HIV-Infected Pediatric Patients
The purpose of this study is to see if it is safe and effective to give adefovir (a new anti-HIV drug) plus nelfinavir to HIV-infected children who are already receiving other anti-HIV medications.
Read the detailed description
During the first phase of the study (Days 1-6), the safety and tolerability of multiple doses of ADF is assessed when administered simultaneously with the patient's reverse transcriptase inhibitor (RTI) regimen. The second phase begins on Day 7 when nelfinavir is added to the therapy regimen for an additional 15 weeks. ADF pharmacokinetics are measured on Days 1, 2, and 7 (on a subset of 18 patients); peak and trough samples are collected on Day 28.
- Conditions
- HIV Infections
- Being tested
- Nelfinavir mesylate, Levocarnitine, Adefovir dipivoxil
- Keywords
- Dose-Response Relationship, Drug, Antiviral Agents, HIV Protease Inhibitors, Disease Progression, RNA, Viral, Adenine, Viral Load, Age Factors, Nelfinavir
- Medical subject headings
- HIV Infections, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nelfinavir mesylateDrug
LevocarnitineDrug
Adefovir dipivoxilDrug
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.
- More trials run by Gilead SciencesThe 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 2
- Primary purpose
- Treatment
- Enrolment
- 36 participants
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002219
- Sponsor's protocol ID
- 232H
- Other IDs
- GS-97-418
- Status last verified
- Nov 1999
- 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 Phase I/II, Open-Label, Multi-Center Study of the Pharmacokinetics, Safety, Tolerance and Activity of Two Dose Levels of Adefovir Dipivoxil (ADF) and Nelfinavir When Added to Antiretroviral Therapy for the Treatment of HIV-Infected Pediatric Patients
- ClinicalTrials.gov ID
- NCT00002219
- Acronym / sponsor ID
- 232H
- Conditions
- HIV Infections
- Keywords
- Dose-Response Relationship, Drug, Antiviral Agents, HIV Protease Inhibitors, Disease Progression, RNA, Viral, Adenine, Viral Load, Age Factors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants
- Lead sponsor
- Gilead SciencesIndustry (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 see if it is safe and effective to give adefovir (a new anti-HIV drug) plus nelfinavir to HIV-infected children who are already receiving other anti-HIV medications.
Detailed description
During the first phase of the study (Days 1-6), the safety and tolerability of multiple doses of ADF is assessed when administered simultaneously with the patient's reverse transcriptase inhibitor (RTI) regimen. The second phase begins on Day 7 when nelfinavir is added to the therapy regimen for an additional 15 weeks. ADF pharmacokinetics are measured on Days 1, 2, and 7 (on a subset of 18 patients); peak and trough samples are collected on Day 28.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 3 months to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Is 3 months to 16 years old.
- Is HIV-positive.
- Has never taken protease inhibitors or has previously taken ritonavir (RTV), saquinavir (SQV), or indinavir (IDV) and is willing to stop the medication at study entry.
- Is taking an anti-HIV drug combination that will not change during at least the 2 weeks prior to study entry.
- Agrees to use effective barrier methods of birth control, such as condoms, during the study.
Key exclusion criteria (7 listed)
- Has ever taken NFV.
- Has a history of opportunistic (AIDS-related) infection.
- Has any disease or illness that would prevent him/her from completing the study, including cancer.
- Has taken certain medications, including protease inhibitors at study entry.
- Is receiving an HIV vaccine at study entry.
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 |
|---|---|---|
| Nelfinavir mesylate | Drug | – |
| Levocarnitine | Drug | – |
| Adefovir dipivoxil | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
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 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nelfinavir mesylate, Levocarnitine and Adefovir dipivoxil in people with HIV Infections, run by Gilead Sciences at 7 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 7 inclusion and 7 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: status not confirmed, 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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.