HIV InfectionsPhase 4NCT00002376
The Effectiveness of HIV RNA Viral Load Testing in Determining Treatment Type in HIV-Infected Patients
A Phase 4 study testing Indinavir sulfate, Lamivudine and Stavudine in people with HIV Infections, run by Merck Sharp & Dohme LLC at 1 site in United States.
Trial summary
To evaluate, in HIV-infected patients whose baseline CD4 count is 300 to 750 cells/mm3, whether an antiretroviral treatment regimen based upon clinical evaluation and CD4 counts plus HIV RNA viral load is more effective than a treatment regimen based upon clinical evaluation and CD4 counts without the use of HIV RNA… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Indinavir sulfate, Lamivudine and Stavudine
- How many people
- 540 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have the following:
- CD4 count >= 300 and <= 750 cells/mm3.
Who cannot join
- Prior Medication:
- Excluded:
- Prior protease inhibitor therapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Foundation Hospital
San Francisco, California, 94118
About this study
Official title: A Randomized Controlled Clinical Study to Determine If the Addition of HIV RNA Viral Load Is an Effective Tool in Determining Treatment Regimens for HIV-Infected Patients
To evaluate, in HIV-infected patients whose baseline CD4 count is 300 to 750 cells/mm3, whether an antiretroviral treatment regimen based upon clinical evaluation and CD4 counts plus HIV RNA viral load is more effective than a treatment regimen based upon clinical evaluation and CD4 counts without the use of HIV RNA viral load information. To assess relative utility of viral load testing in determining therapeutic choice by the surrogate marker of CD4 cell counts after 48 weeks of therapy.
It is hypothesized that among HIV-infected patients whose baseline CD4 count is in the range of 300 to 750 cells/mm3, those patients who incorporate initial and periodic viral RNA measurements in their therapeutic decisions will have higher CD4 counts after 48 weeks than patients whose therapeutic decisions do not incorporate initial and periodic viral RNA measurements.
Read the detailed description
It is hypothesized that among HIV-infected patients whose baseline CD4 count is in the range of 300 to 750 cells/mm3, those patients who incorporate initial and periodic viral RNA measurements in their therapeutic decisions will have higher CD4 counts after 48 weeks than patients whose therapeutic decisions do not incorporate initial and periodic viral RNA measurements.
Approximately 540 patients are stratified on the basis of baseline CD4 counts and are randomized to one of two treatment groups: 1. viral RNA treatment group or 2. non viral RNA treatment group. Treatment modification is based upon CD4 count, viral RNA levels (group 1 only) and clinical evaluation. Patients receive one of the three antiretroviral treatments:
- No antiretroviral therapy.
- Double reverse transcriptase inhibitor (RTI) therapy consisting of any two therapy combinations of: didanosine (ddI), lamivudine (3TC), stavudine (d4T) or zidovudine (ZDV), based upon the treating physician's judgment. The preferred combinations are ZDV + 3TC, d4T + 3TC or ddI + d4T.
- Triple antiretroviral therapy consisting of double antiretroviral therapy plus indinavir.
Treatment decisions are based upon a standardized algorithm as follows:
CD4 count 500-750 + viral RNA < 10,000:
Group 1: No retroviral therapy. Group 2: No retroviral therapy.
CD4 count 500-750 + viral RNA >= 10,000:
Group 1: Triple therapy. Group 2: No retroviral therapy.
CD4 count 300-499 + viral RNA < 10,000:
Group 1: Double retroviral therapy. Group 2: Double retroviral therapy.
CD4 count 300-499 + viral RNA >= 10,000:
Group 1: Triple therapy. Group 2: Double retroviral therapy.
CD4 count 200-299 + viral RNA < 10,000:
Group 1: Maintain same retroviral therapy unless: there is a CD4 count decrease of 25-49% within 24 weeks of the count falling in the range of 300-499 in which case both retroviral therapies are changed, there is a CD4 count decrease of >= 50% within the 48 weeks of therapy from the time the CD4 count fell within the range of 300-499 in which case triple therapy is initiated, or there is an AIDS-defining illness in which case triple therapy is initiated.
Group 2: Same as Group 1.
CD4 count 200-299 + viral RNA >= 10,000:
Group 1: Triple therapy. Group 2: Maintain same retroviral therapy unless: there is a CD4 count decrease of 25-49% within 24 weeks of the count falling in the range of 300-499 in which case both retroviral therapies are changed, there is a CD4 count decrease of >= 50% within the 48 weeks of therapy from the time the CD4 count fell within the range of 300-499 in which case triple therapy is initiated, or there is an AIDS-defining illness in which case triple therapy is initiated.
CD4 count < 200:
Group 1: Triple therapy. Group 2: Triple therapy.
- Conditions
- HIV Infections
- Being tested
- Indinavir sulfate, Lamivudine, Stavudine, Zidovudine, Didanosine
- Keywords
- HIV-1, CD4 Lymphocyte Count, RNA, Viral, 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
LamivudineDrug
StavudineDrug
ZidovudineDrug
DidanosineDrug
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 Merck Sharp & Dohme LLCThe 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 4
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Enrolment
- 540 participants
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002376
- Sponsor's protocol ID
- 246F
- Other IDs
- MK-0639, 056-00
- Status last verified
- Jun 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 Controlled Clinical Study to Determine If the Addition of HIV RNA Viral Load Is an Effective Tool in Determining Treatment Regimens for HIV-Infected Patients
- ClinicalTrials.gov ID
- NCT00002376
- Acronym / sponsor ID
- 246F
- Conditions
- HIV Infections
- Keywords
- HIV-1, CD4 Lymphocyte Count, RNA, Viral, Anti-HIV Agents, Viral Load
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 540 participants
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (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.
To evaluate, in HIV-infected patients whose baseline CD4 count is 300 to 750 cells/mm3, whether an antiretroviral treatment regimen based upon clinical evaluation and CD4 counts plus HIV RNA viral load is more effective than a treatment regimen based upon clinical evaluation and CD4 counts without the use of HIV RNA viral load information. To assess relative utility of viral load testing in determining therapeutic choice by the surrogate marker of CD4 cell counts after 48 weeks of therapy.
It is hypothesized that among HIV-infected patients whose baseline CD4 count is in the range of 300 to 750 cells/mm3, those patients who incorporate initial and periodic viral RNA measurements in their therapeutic decisions will have higher CD4 counts after 48 weeks than patients whose therapeutic decisions do not incorporate initial and periodic viral RNA measurements.
Detailed description
It is hypothesized that among HIV-infected patients whose baseline CD4 count is in the range of 300 to 750 cells/mm3, those patients who incorporate initial and periodic viral RNA measurements in their therapeutic decisions will have higher CD4 counts after 48 weeks than patients whose therapeutic decisions do not incorporate initial and periodic viral RNA measurements.
Approximately 540 patients are stratified on the basis of baseline CD4 counts and are randomized to one of two treatment groups: 1. viral RNA treatment group or 2. non viral RNA treatment group. Treatment modification is based upon CD4 count, viral RNA levels (group 1 only) and clinical evaluation. Patients receive one of the three antiretroviral treatments:
- No antiretroviral therapy.
- Double reverse transcriptase inhibitor (RTI) therapy consisting of any two therapy combinations of: didanosine (ddI), lamivudine (3TC), stavudine (d4T) or zidovudine (ZDV), based upon the treating physician's judgment. The preferred combinations are ZDV + 3TC, d4T + 3TC or ddI + d4T.
- Triple antiretroviral therapy consisting of double antiretroviral therapy plus indinavir.
Treatment decisions are based upon a standardized algorithm as follows:
CD4 count 500-750 + viral RNA < 10,000:
Group 1: No retroviral therapy. Group 2: No retroviral therapy.
CD4 count 500-750 + viral RNA >= 10,000:
Group 1: Triple therapy. Group 2: No retroviral therapy.
CD4 count 300-499 + viral RNA < 10,000:
Group 1: Double retroviral therapy. Group 2: Double retroviral therapy.
CD4 count 300-499 + viral RNA >= 10,000:
Group 1: Triple therapy. Group 2: Double retroviral therapy.
CD4 count 200-299 + viral RNA < 10,000:
Group 1: Maintain same retroviral therapy unless: there is a CD4 count decrease of 25-49% within 24 weeks of the count falling in the range of 300-499 in which case both retroviral therapies are changed, there is a CD4 count decrease of >= 50% within the 48 weeks of therapy from the time the CD4 count fell within the range of 300-499 in which case triple therapy is initiated, or there is an AIDS-defining illness in which case triple therapy is initiated.
Group 2: Same as Group 1.
CD4 count 200-299 + viral RNA >= 10,000:
Group 1: Triple therapy. Group 2: Maintain same retroviral therapy unless: there is a CD4 count decrease of 25-49% within 24 weeks of the count falling in the range of 300-499 in which case both retroviral therapies are changed, there is a CD4 count decrease of >= 50% within the 48 weeks of therapy from the time the CD4 count fell within the range of 300-499 in which case triple therapy is initiated, or there is an AIDS-defining illness in which case triple therapy is initiated.
CD4 count < 200:
Group 1: Triple therapy. Group 2: Triple therapy.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- CD4 count >= 300 and <= 750 cells/mm3.
Key exclusion criteria (3 listed)
- Prior protease inhibitor therapy.
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 | – |
| Zidovudine | Drug | – |
| Didanosine | 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 Phase 4 study testing Indinavir sulfate, Lamivudine and Stavudine in people with HIV Infections, run by Merck Sharp & Dohme LLC 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 2 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 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 24 Jun 2005.