HIV InfectionsPhase 2NCT00005118
The Safety and Effectiveness of Indinavir Plus Ritonavir Plus Two NRTIs in HIV-Infected Patients Who Need Early Intervention Treatment
A Phase 2 study testing Indinavir sulfate and Ritonavir in people with HIV Infections, run by Merck Sharp & Dohme LLC at 40 sites in United States.
Trial summary
The purpose of this study is to see if it is safe and effective to give indinavir plus ritonavir plus 2 NRTIs to HIV-infected patients who need early intervention treatment. 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 and Ritonavir
- How many people
- 100 participants
- Where
- 40 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 2
- 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 may be eligible for this study if they:
- Are HIV-positive.
- Are 18 years of age or older.
- Have a CD4 cell count of at least 50 cells/mm3.
- Have a viral load (level of HIV in the blood) of at least 400 copies/ml but no more than 20,000 copies/ml.
- Have had an initial response to protease inhibitor therapy with a viral load of less than 400 copies/ml in two consecutive tests at least 1 week apart.
Show all 9Show fewer
- Have been on anti-HIV (antiretroviral) treatment including indinavir or nelfinavir for at least 16 weeks.
- Have had virologic failure (two consecutive viral loads that were greater than or equal to 400 copies/ml and less than or equal to 20,000 copies/ml at least 1 week apart) that is not due to another infection, vaccination, or a temporary stop in treatment.
- Are naive to at least one of the selected NRTIs.
Who cannot join
None listed.
Trial locations and contacts
40 sites in 1 country.
40 sites in 1 country
United States40 sites
IDC Research Initiative
Altamonte Springs, Florida, 32701
Institute of Human Virology
Baltimore, Maryland, 21201
Pacific Oaks Research
Beverly Hills, California, 90211
Thomas Coffman MD
Boise, Idaho, 83712
New England Med Ctr
Boston, Massachusetts, 02111
Cooper Hospital Early Intervention Program
Camden, New Jersey, 08103
Chicago Ctr for Clinical Research
Chicago, Illinois, 60610
Northwestern Univ / Infect Dis Div / Pasavant Pav 828
Chicago, Illinois, 60611
The CORE Ctr
Chicago, Illinois, 60612
Benjamin Young
Denver, Colorado, 80220
University of Connecticut Health Center
Farmington, Connecticut, 06030
Univ of Texas Med Branch / Div of Infectious Dis
Galveston, Texas, 775550835
Thomas Street Clinic
Houston, Texas, 77009
Ocean View Internal Medicine
Long Beach, California, 90803
Bisher Akil
Los Angeles, California, 90046
Tower Infectious Diseases / Med Associates Inc
Los Angeles, California, 90048
University of Louisville / ID Division
Louisville, Kentucky, 40202
Mercer University School of Medicine
Macon, Georgia, 31201
Mt Vernon Hosp
Mount Vernon, New York, 10550
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112
Gramercy Park Physicians LLP
New York, New York, 10003
St Luke Roosevelt Hosp
New York, New York, 10011
St Vincents Hosp / Clinical Research Program
New York, New York, 10011
Bellevue Hosp Ctr
New York, New York, 10016
Mount Sinai Med Ctr
New York, New York, 100296574
Oklahoma Univ Health Science Ctr
Oklahoma City, Oklahoma, 73104
Anderson Clinical Research
Pittsburgh, Pennsylvania, 15213
Fanno Creek Clinic
Portland, Oregon, 97219
Univ of Texas Health Sciences Ctr
San Antonio, Texas, 782847838
UCSD Med Ctr - Owen Clinic
San Diego, California, 921038681
HIV Institute / Davies Med Ctr
San Francisco, California, 94114
San Francisco Veterans Adm Med Cntr
San Francisco, California, 94121
Dr Ronald Nahass
Somerville, New Jersey, 08876
SUNY at Stony Brook / Div of Infectious Disease
Stony Brook, New York, 117948153
Hillsborough County Health Dept
Tampa, Florida, 33602
Avalar Medical Group
Tarzana, California, 91356
Bronx Veterans Affairs Med Ctr
The Bronx, New York, 10468
Harbor - UCLA Med Ctr
Torrance, California, 90502
Univ of Kansas School of Medicine
Wichita, Kansas, 67214
Wake Forest Univ School of Medicine
Winston-Salem, North Carolina, 27157
About this study
Official title: A Multicenter, Open-Label, 24-Week Study to Evaluate the Efficacy and Safety of Indinavir Sulfate 800 Mg and Ritonavir 200 Mg b.i.d. Plus 2 NRTIs b.i.d. in HIV-1 Infected Individuals Who Require Early Treatment Intervention
The purpose of this study is to see if it is safe and effective to give indinavir plus ritonavir plus 2 NRTIs to HIV-infected patients who need early intervention treatment.
Read the detailed description
Patients receive indinavir bid plus ritonavir bid, plus 2 NRTIs bid (2 new NRTIs or 1 new NRTI and 1 NRTI without evidence of resistance). CD4 cell counts and plasma viral RNA are measured every 4 weeks for the duration of the study. Physical examination and laboratory tests of blood and urine are performed every 4 weeks for the duration of the study. Chest x-ray and 12-lead ECG are done prestudy.
- Conditions
- HIV Infections
- Being tested
- Indinavir sulfate, Ritonavir
- Keywords
- HIV-1, Drug Therapy, Combination, HIV Protease Inhibitors, Ritonavir, Indinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load, Nelfinavir
- 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
RitonavirDrug
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 2
- Primary purpose
- Treatment
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005118
- Sponsor's protocol ID
- 246V
- Other IDs
- CRX481, 107-00
- Status last verified
- Jul 2001
- First submitted
- 7 Apr 2000
- 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, 24-Week Study to Evaluate the Efficacy and Safety of Indinavir Sulfate 800 Mg and Ritonavir 200 Mg b.i.d. Plus 2 NRTIs b.i.d. in HIV-1 Infected Individuals Who Require Early Treatment Intervention
- ClinicalTrials.gov ID
- NCT00005118
- Acronym / sponsor ID
- 246V
- Conditions
- HIV Infections
- Keywords
- HIV-1, Drug Therapy, Combination, HIV Protease Inhibitors, Ritonavir, Indinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 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 see if it is safe and effective to give indinavir plus ritonavir plus 2 NRTIs to HIV-infected patients who need early intervention treatment.
Detailed description
Patients receive indinavir bid plus ritonavir bid, plus 2 NRTIs bid (2 new NRTIs or 1 new NRTI and 1 NRTI without evidence of resistance). CD4 cell counts and plasma viral RNA are measured every 4 weeks for the duration of the study. Physical examination and laboratory tests of blood and urine are performed every 4 weeks for the duration of the study. Chest x-ray and 12-lead ECG are done prestudy.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Are HIV-positive.
- Are 18 years of age or older.
- Have a CD4 cell count of at least 50 cells/mm3.
- Have a viral load (level of HIV in the blood) of at least 400 copies/ml but no more than 20,000 copies/ml.
- Have had an initial response to protease inhibitor therapy with a viral load of less than 400 copies/ml in two consecutive tests at least 1 week apart.
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 | – |
| Ritonavir | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
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.
40 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Indinavir sulfate and Ritonavir in people with HIV Infections, run by Merck Sharp & Dohme LLC at 40 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 9 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: status not confirmed, 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 40 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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.