HIV InfectionsNCT00002398
Safety and Effectiveness of Giving Adefovir (Preveon) Plus Other Anti-HIV Drugs to HIV-Infected Patients Who Have Not Responded to Other Anti-HIV Drug Combinations
A study testing Levocarnitine and Adefovir dipivoxil in people with HIV Infections, run by Gilead Sciences at 1 site in United States.
Trial summary
The purpose of this study is to see if it is safe and effective to give adefovir plus other anti-HIV drugs to HIV-infected patients who have failed other anti-HIV drug combinations. This study will try to make adefovir available to all AIDS patients who need it. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Levocarnitine and Adefovir dipivoxil
- How many people
- Not given
- Where
- 1 siteUnited States
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- You may be eligible for this study if you:
- Are HIV-positive.
- Have a CD4 cell count of 50 cells/mm3 or less within the past 2 months.
- Have a viral load (level of HIV in the body) of 30,000 copies/ml or more within the past 2 months.
- Are at least 13 years old (need consent of parent or guardian if under 18).
- Have failed to respond to an anti-HIV drug combination that included at least 2 nucleoside reverse transcriptase inhibitors and at least 1 protease inhibitor (PI).
- Do not have any other anti-HIV treatment options left.
- Agree to use effective methods of birth control during the study.
Who cannot join
- You will not be eligible for this study if you:
- Have certain serious medical conditions that would prevent you from completing the study, including serious kidney disorders.
- Have taken certain medications, including certain treatments for opportunistic (HIV-related) diseases.
- Are pregnant or breast-feeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-Label Expanded Access Program to Evaluate the Safety of Preveon (Adefovir Dipivoxil) at Two Dose Levels When Used in Combination With Other Antiretroviral Agents for the Treatment of Patients With HIV Infection Who Have Failed Other Antiretroviral Therapy and Have Limited Treatment Options
The purpose of this study is to see if it is safe and effective to give adefovir plus other anti-HIV drugs to HIV-infected patients who have failed other anti-HIV drug combinations. This study will try to make adefovir available to all AIDS patients who need it.
Some patients do not respond to anti-HIV drug combinations, even when different combinations are tried. Adefovir may be able to help these patients fight HIV.
Read the detailed description
Recent studies indicate that the use of triple-combination therapy, in particular the combinations of reverse transcriptase inhibitors and a protease inhibitor, can result in a significant decrease in plasma HIV-1 RNA levels and an increase in CD4 cell count. Continued follow-up of patients taking triple-combination drug regimens has in some cases demonstrated sustained suppression of plasma HIV-1 RNA levels for up to 18 months. Furthermore, despite the potent antiviral effect of some triple combinations, a percentage of patients continue to have measurable levels (more than 500 copies/ml) of HIV-1 RNA in plasma, even when treated with a combination of 2 reverse transcriptase inhibitors and indinavir. Over time, some patients experience a rebound of plasma HIV-1 RNA for reasons that are not well understood. [AS PER AMENDMENT 7/8/98: Randomization to 2 dose levels may allow more patients to derive therapeutic benefit from Preveon by minimizing adverse effects.]
Patients not previously enrolled in clinical trials of Preveon are randomized to 1 of 2 doses of Preveon orally once daily and L-carnitine orally once daily. [AS PER AMENDMENT 7/8/98: Patients must receive other antiretroviral agents concomitantly with Preveon; at least 1 other antiretroviral agent must be added with Preveon that was not previously administered to the patient.Patients previously enrolled in Preveon clinical trials who "roll in" to expanded access and who have received at least 16 weeks of Preveon receive open-label Preveon orally once daily and L-carnitine orally once daily, taken with or without food at the same time each day.] All patients enrolled in expanded access are randomized in a 1:1 fashion to 1 of 2 doses taken orally once daily. Patients initially assigned to the higher dose will have their Preveon dose reduced to the lower dose at Week 16 of treatment. Patients initially assigned to the lower dose continue this dose unless dose modification to an even lower dose for toxicity is required. [AS PER AMENDMENT 7/8/98: Additional informed consent is needed for this reduction due to limited efficacy of the lower dosage in treating HIV infection.]
- Conditions
- HIV Infections
- Being tested
- Levocarnitine, Adefovir dipivoxil
- Keywords
- HIV-1, Acquired Immunodeficiency Syndrome, Adenine, Anti-HIV Agents
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 N/A
- Primary purpose
- Treatment
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002398
- Sponsor's protocol ID
- 232G
- Other IDs
- GS-97-423
- Status last verified
- Dec 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 Randomized, Open-Label Expanded Access Program to Evaluate the Safety of Preveon (Adefovir Dipivoxil) at Two Dose Levels When Used in Combination With Other Antiretroviral Agents for the Treatment of Patients With HIV Infection Who Have Failed Other Antiretroviral Therapy and Have Limited Treatment Options
- ClinicalTrials.gov ID
- NCT00002398
- Acronym / sponsor ID
- 232G
- Conditions
- HIV Infections
- Keywords
- HIV-1, Acquired Immunodeficiency Syndrome, Adenine, Anti-HIV Agents
- Study type
- Interventional
- Recruitment status
- Completed
- 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 plus other anti-HIV drugs to HIV-infected patients who have failed other anti-HIV drug combinations. This study will try to make adefovir available to all AIDS patients who need it.
Some patients do not respond to anti-HIV drug combinations, even when different combinations are tried. Adefovir may be able to help these patients fight HIV.
Detailed description
Recent studies indicate that the use of triple-combination therapy, in particular the combinations of reverse transcriptase inhibitors and a protease inhibitor, can result in a significant decrease in plasma HIV-1 RNA levels and an increase in CD4 cell count. Continued follow-up of patients taking triple-combination drug regimens has in some cases demonstrated sustained suppression of plasma HIV-1 RNA levels for up to 18 months. Furthermore, despite the potent antiviral effect of some triple combinations, a percentage of patients continue to have measurable levels (more than 500 copies/ml) of HIV-1 RNA in plasma, even when treated with a combination of 2 reverse transcriptase inhibitors and indinavir. Over time, some patients experience a rebound of plasma HIV-1 RNA for reasons that are not well understood. [AS PER AMENDMENT 7/8/98: Randomization to 2 dose levels may allow more patients to derive therapeutic benefit from Preveon by minimizing adverse effects.]
Patients not previously enrolled in clinical trials of Preveon are randomized to 1 of 2 doses of Preveon orally once daily and L-carnitine orally once daily. [AS PER AMENDMENT 7/8/98: Patients must receive other antiretroviral agents concomitantly with Preveon; at least 1 other antiretroviral agent must be added with Preveon that was not previously administered to the patient.Patients previously enrolled in Preveon clinical trials who "roll in" to expanded access and who have received at least 16 weeks of Preveon receive open-label Preveon orally once daily and L-carnitine orally once daily, taken with or without food at the same time each day.] All patients enrolled in expanded access are randomized in a 1:1 fashion to 1 of 2 doses taken orally once daily. Patients initially assigned to the higher dose will have their Preveon dose reduced to the lower dose at Week 16 of treatment. Patients initially assigned to the lower dose continue this dose unless dose modification to an even lower dose for toxicity is required. [AS PER AMENDMENT 7/8/98: Additional informed consent is needed for this reduction due to limited efficacy of the lower dosage in treating HIV infection.]
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Are HIV-positive.
- Have a CD4 cell count of 50 cells/mm3 or less within the past 2 months.
- Have a viral load (level of HIV in the body) of 30,000 copies/ml or more within the past 2 months.
- Are at least 13 years old (need consent of parent or guardian if under 18).
- Have failed to respond to an anti-HIV drug combination that included at least 2 nucleoside reverse transcriptase inhibitors and at least 1 protease inhibitor (PI).
Key exclusion criteria (4 listed)
- Have certain serious medical conditions that would prevent you from completing the study, including serious kidney disorders.
- Have taken certain medications, including certain treatments for opportunistic (HIV-related) diseases.
- Are pregnant or breast-feeding.
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 |
|---|---|---|
| Levocarnitine | Drug | – |
| Adefovir dipivoxil | 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Levocarnitine and Adefovir dipivoxil in people with HIV Infections, run by Gilead Sciences at 1 site 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 8 inclusion and 4 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 1 site 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.
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.