HIV InfectionsPhase 3NCT00002406
A Comparison of Two Dose Levels of Indinavir Combined With Two Nucleoside Analogue Reverse Transcriptase Inhibitors (NRTIs) in HIV-Infected Patients
A Phase 3 study testing Indinavir sulfate in people with HIV Infections, run by Merck Sharp & Dohme LLC at 29 sites in United States.
Trial summary
The purpose of this study is to determine if two dose levels of indinavir combined with two nucleoside analogue reverse transcriptase inhibitors (NRTIs) have the same effect on plasma viral load (level of HIV in the blood). Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Indinavir sulfate
- How many people
- 350 participants
- Where
- 29 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 3
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must have:
- Documented HIV-1 seropositive status.
- CD4 count greater than 100 cells/mm3.
- Parental consent for patients under 18.
Who cannot join
None listed.
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
United States29 sites
Akron City Hospital
Akron, Ohio, 44304
Albany Med College / Div of HIV Medicine
Albany, New York, 12208
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
Ponce de Leon Ctr
Atlanta, Georgia, 30308
Natl Naval Med Ctr / Special Immunology Clinic
Bethesda, Maryland, 20889
1917 Research Clinic
Birmingham, Alabama, 35294
Brigham and Women's Hosp
Boston, Massachusetts, 02115
Boston Med Ctr / Clinical Research Office
Boston, Massachusetts, 02118
SUNY / Health Science Ctr at Brooklyn
Brooklyn, New York, 11203
Education & Research Building
Camden, New Jersey, 08103
Northwestern Univ Med School
Chicago, Illinois, 60611
Rush Presbyterian St Lukes Med Ctr
Chicago, Illinois, 60612
Univ Health Ctr 7D
Detroit, Michigan, 48201
New York Hosp of Queens / AIDS Ctr
Flushing, New York, 11355
HIV Clinical Research
Fort Lauderdale, Florida, 33316
Houston Clinical Research Network / Southhampton Med Group
Houston, Texas, 77098
Kansas City Free Health Clinic
Kansas City, Missouri, 64111
Kaiser Permanente / Infectious Disease
Los Angeles, California, 90027
Tower ID Med Associates
Los Angeles, California, 90048
Univ of Miami School of Medicine
Miami, Florida, 33136
CRIA
New York, New York, 10001
St Vincents Hosp and Med Ctr / Div of HIV Med
New York, New York, 10011
Anderson Clinical Research
New York, New York, 10016
Thomas Jefferson Univ
Philadelphia, Pennsylvania, 19107
Anderson Clinical Research
Pittsburgh, Pennsylvania, 15213
Ctr for AIDS Research / Education and Service (CARES)
Sacramento, California, 95814
Univ of Utah School Of Medicine / Div of Infec Disease
Salt Lake City, Utah, 84132
San Francisco Gen Hosp / UCSF AIDS Program
San Francisco, California, 94110
Garden State Infectious Diseases / E I P Kennedy Health Sys
Voorhees Township, New Jersey, 08043
About this study
Official title: A Multicenter, Open-Label, Randomized, 24-Week Study to Compare the Safety and Activity of Indinavir Sulphate, 800 Mg q 8h Versus 1,200 Mg q 12h in HIV-Infected Individuals Having Plasma Viral RNA Less Than 400 Copies/Ml, on Concomitant Therapy With 2 Nucleoside Analogue Reverse Transcriptase Inhibitors (NRTI)
The purpose of this study is to determine if two dose levels of indinavir combined with two nucleoside analogue reverse transcriptase inhibitors (NRTIs) have the same effect on plasma viral load (level of HIV in the blood).
Read the detailed description
In this open-label study 350 seropositive HIV-1 men and women are first stratified according to baseline plasma viral RNA (less than 400 copies/mL vs negative plasma viral RNA result) then randomized into one of two arms:
Arm 1: Indinavir (800 mg, q8h) plus two pre-existing NRTIs. Arm 2: Indinavir (1,200 mg, q12h) plus two pre-existing NRTIs. Plasma viral RNA will be measured every 4 weeks for the duration of the 24-week study.
- Conditions
- HIV Infections
- Being tested
- Indinavir sulfate
- Keywords
- HIV-1, Dose-Response Relationship, Drug, HIV Protease Inhibitors, Indinavir, RNA, Viral, Reverse Transcriptase Inhibitors
- 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
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 3
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 350 participants
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002406
- Sponsor's protocol ID
- 246P
- Other IDs
- MK-0639
- 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 Multicenter, Open-Label, Randomized, 24-Week Study to Compare the Safety and Activity of Indinavir Sulphate, 800 Mg q 8h Versus 1,200 Mg q 12h in HIV-Infected Individuals Having Plasma Viral RNA Less Than 400 Copies/Ml, on Concomitant Therapy With 2 Nucleoside Analogue Reverse Transcriptase Inhibitors (NRTI)
- ClinicalTrials.gov ID
- NCT00002406
- Acronym / sponsor ID
- 246P
- Conditions
- HIV Infections
- Keywords
- HIV-1, Dose-Response Relationship, Drug, HIV Protease Inhibitors, Indinavir, RNA, Viral, Reverse Transcriptase Inhibitors
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 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.
The purpose of this study is to determine if two dose levels of indinavir combined with two nucleoside analogue reverse transcriptase inhibitors (NRTIs) have the same effect on plasma viral load (level of HIV in the blood).
Detailed description
In this open-label study 350 seropositive HIV-1 men and women are first stratified according to baseline plasma viral RNA (less than 400 copies/mL vs negative plasma viral RNA result) then randomized into one of two arms:
Arm 1: Indinavir (800 mg, q8h) plus two pre-existing NRTIs. Arm 2: Indinavir (1,200 mg, q12h) plus two pre-existing NRTIs. Plasma viral RNA will be measured every 4 weeks for the duration of the 24-week study.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Documented HIV-1 seropositive status.
- CD4 count greater than 100 cells/mm3.
- Parental consent for patients under 18.
Key exclusion criteria (0 listed)
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 | – |
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.
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Indinavir sulfate in people with HIV Infections, run by Merck Sharp & Dohme LLC at 29 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 4 inclusion and 0 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 29 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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.