HIV InfectionsNCT00002236
A Study to Find the Best Dosing Schedule for Delavirdine, Zidovudine, and Indinavir in HIV-Positive Patients
A study testing Indinavir sulfate, Delavirdine mesylate and Zidovudine in people with HIV Infections, run by Pharmacia and Upjohn at 6 sites in United States.
Trial summary
The purpose of this study is to see whether it is better to take delavirdine (DLV) plus indinavir (IDV) plus zidovudine (ZDV) twice a day or three times a day. 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 Zidovudine
- How many people
- 32 participants
- Where
- 6 sitesUnited 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
- You may be eligible for this study if you:
- Are HIV-positive.
- Have a viral load (level of HIV in the blood) of at least 20,000 copies/ml.
- Have a CD4 cell count of at least 50 cells/mm3.
- Are at least 14 years old (consent of parent or guardian is required if under 18).
Who cannot join
- You will not be eligible for this study if you:
- Have ever taken an anti-HIV drug other than ZDV.
- Have taken ZDV for more than 1 month.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Infectious Disease Physicians Inc
Annandale, Virginia, 22203
AIDS Healthcare Foundation
Los Angeles, California, 90027
Univ of Tennessee / Div of Infect Dis / Dept of Med
Memphis, Tennessee, 38165
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, 10019
Anderson Clinical Research
Pittsburgh, Pennsylvania, 15213
UCSF AIDS Research Institute
San Francisco, California, 94105
About this study
Official title: An Open-Label, Parallel Group, Pilot Study of Safety, Tolerance, Pharmacokinetics and Pharmacodynamics of BID and TID Regimens of Delavirdine Mesylate, Zidovudine, and Indinavir Sulfate in HIV-1 Infected Individuals
The purpose of this study is to see whether it is better to take delavirdine (DLV) plus indinavir (IDV) plus zidovudine (ZDV) twice a day or three times a day.
Read the detailed description
Patients are divided into 2 treatment groups; the groups are balanced with respect to viral load. Group A receives ZDV, DLV, and IDV 3 times daily. Group B receives ZDV, DLV, and IDV 2 times daily. Patients are evaluated for changes from baseline in viral load and CD4 cell count.
- Conditions
- HIV Infections
- Being tested
- Indinavir sulfate, Delavirdine mesylate, Zidovudine
- Keywords
- Drug Therapy, Combination, Zidovudine, Drug Administration Schedule, HIV Protease Inhibitors, CD4 Lymphocyte Count, Indinavir, Delavirdine, Reverse Transcriptase Inhibitors, Anti-HIV Agents, 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
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
- Masking
- None (open label)
- Enrolment
- 32 participants
Sponsor and investigators
- Lead sponsor
- Pharmacia and Upjohn
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002236
- Sponsor's protocol ID
- 228G
- Other IDs
- M/3331/0072
- Status last verified
- Apr 2000
- 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, Parallel Group, Pilot Study of Safety, Tolerance, Pharmacokinetics and Pharmacodynamics of BID and TID Regimens of Delavirdine Mesylate, Zidovudine, and Indinavir Sulfate in HIV-1 Infected Individuals
- ClinicalTrials.gov ID
- NCT00002236
- Acronym / sponsor ID
- 228G
- Conditions
- HIV Infections
- Keywords
- Drug Therapy, Combination, Zidovudine, Drug Administration Schedule, HIV Protease Inhibitors, CD4 Lymphocyte Count, Indinavir, Delavirdine, Reverse Transcriptase Inhibitors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 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 whether it is better to take delavirdine (DLV) plus indinavir (IDV) plus zidovudine (ZDV) twice a day or three times a day.
Detailed description
Patients are divided into 2 treatment groups; the groups are balanced with respect to viral load. Group A receives ZDV, DLV, and IDV 3 times daily. Group B receives ZDV, DLV, and IDV 2 times daily. Patients are evaluated for changes from baseline in viral load and CD4 cell count.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Are HIV-positive.
- Have a viral load (level of HIV in the blood) of at least 20,000 copies/ml.
- Have a CD4 cell count of at least 50 cells/mm3.
- Are at least 14 years old (consent of parent or guardian is required if under 18).
Key exclusion criteria (3 listed)
- Have ever taken an anti-HIV drug other than ZDV.
- Have taken ZDV for more than 1 month.
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 | – |
| 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.
6 sites 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 Zidovudine in people with HIV Infections, run by Pharmacia and Upjohn at 6 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 5 inclusion and 3 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 6 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.
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.