HIV InfectionsNCT00002401
A Study of Delavirdine Used Together With Other Anti-HIV Drugs in HIV-Infected Patients
A study testing Indinavir sulfate, Delavirdine mesylate and Lamivudine in people with HIV Infections, run by Pharmacia and Upjohn at 1 site in United States.
Trial summary
The purpose of this study is to see if it is safe and effective to give delavirdine (DLV) in combination with two or three other drugs to HIV-infected patients. The drugs to be used in combination with DLV are zidovudine (ZDV), indinavir (IDV), and lamivudine (3TC). Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Indinavir sulfate, Delavirdine mesylate and Lamivudine
- How many people
- 160 participants
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Prior Medication:
- Allowed:
- Less than 1 month prior treatment with zidovudine.
Who cannot join
- Prior Medication:
- Excluded:
- Prior indinavir.
- Prior lamivudine.
- Prior protease inhibitors.
- Prior non-nucleoside reverse transcriptase inhibitors.
Show all 10Show fewer
- 1 month or more prior zidovudine.
- 1. HIV-1 positive.
- CD4 coun tis above 50.
- HIV-1 RNA levels greater than 20,000.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label Randomized Study of Delavirdine Mesylate (DLV, Rescriptor) in Triple and Quadruple Combinations With Zidovudine (ZDV), Indinavir (IDV), and Lamivudine (3TC) in HIV-1 Infected Individuals
The purpose of this study is to see if it is safe and effective to give delavirdine (DLV) in combination with two or three other drugs to HIV-infected patients. The drugs to be used in combination with DLV are zidovudine (ZDV), indinavir (IDV), and lamivudine (3TC).
Read the detailed description
In this open-label pilot study, patients are randomized to 1of the following 4 arms for 24 weeks:
Arm 1 (40 patients): DLV plus ZDV plus IDV. Arm 2 (40 patients): DLV plus IDV plus 3TC*. Arm 3 (40 patients): DLV plus ZDV plus IDV plus 3TC. Arm 4 (40 patients): ZDV plus IDV plus 3TC.
- Dose determined by body weight. Patients may opt to continue on study for 24 additional weeks at the discretion of the investigator.
- Conditions
- HIV Infections
- Being tested
- Indinavir sulfate, Delavirdine mesylate, Lamivudine, Zidovudine
- Keywords
- HIV-1, Zidovudine, HIV Protease Inhibitors, Lamivudine, Indinavir, RNA, Viral, Delavirdine, 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
Delavirdine mesylateDrug
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 N/A
- Primary purpose
- Treatment
- Enrolment
- 160 participants
Sponsor and investigators
- Lead sponsor
- Pharmacia and Upjohn
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002401
- Sponsor's protocol ID
- 228F
- Other IDs
- 0074
- Status last verified
- Jan 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
- An Open-Label Randomized Study of Delavirdine Mesylate (DLV, Rescriptor) in Triple and Quadruple Combinations With Zidovudine (ZDV), Indinavir (IDV), and Lamivudine (3TC) in HIV-1 Infected Individuals
- ClinicalTrials.gov ID
- NCT00002401
- Acronym / sponsor ID
- 228F
- Conditions
- HIV Infections
- Keywords
- HIV-1, Zidovudine, HIV Protease Inhibitors, Lamivudine, Indinavir, RNA, Viral, Delavirdine, Reverse Transcriptase Inhibitors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants
- Lead sponsor
- Pharmacia and UpjohnIndustry (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 delavirdine (DLV) in combination with two or three other drugs to HIV-infected patients. The drugs to be used in combination with DLV are zidovudine (ZDV), indinavir (IDV), and lamivudine (3TC).
Detailed description
In this open-label pilot study, patients are randomized to 1of the following 4 arms for 24 weeks:
Arm 1 (40 patients): DLV plus ZDV plus IDV. Arm 2 (40 patients): DLV plus IDV plus 3TC*. Arm 3 (40 patients): DLV plus ZDV plus IDV plus 3TC. Arm 4 (40 patients): ZDV plus IDV plus 3TC.
- Dose determined by body weight. Patients may opt to continue on study for 24 additional weeks at the discretion of the investigator.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Less than 1 month prior treatment with zidovudine.
Key exclusion criteria (10 listed)
- Prior indinavir.
- Prior lamivudine.
- Prior protease inhibitors.
- Prior non-nucleoside reverse transcriptase inhibitors.
- 1 month or more prior zidovudine.
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 | – |
| Delavirdine mesylate | 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.
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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 Indinavir sulfate, Delavirdine mesylate and Lamivudine in people with HIV Infections, run by Pharmacia and Upjohn 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 3 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 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.