HIV InfectionsPhase 2NCT00002241
Safety and Effectiveness of an Anti-HIV Drug Combination Taken Twice Daily
A Phase 2 study testing Indinavir sulfate, Ritonavir and Lamivudine in people with HIV Infections, run by Merck Sharp & Dohme LLC at 18 sites in United States.
Trial summary
The purpose of this study is to see whether taking indinavir (IDV) plus ritonavir (RTV) plus stavudine (d4T) plus lamivudine (3TC) 2 times each day is safe and can lower the 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, Ritonavir and Lamivudine
- How many people
- 80 participants
- Where
- 18 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients may be eligible for this study if they:
- Are HIV-positive.
- Have a CD4 cell count of 75 cells/mm3 or more and a viral load of 5,000 copies/ml or more.
- Are age 16 or older (consent of a parent or guardian required if under 18).
- Agree to practice abstinence or use barrier methods of birth control (such as condoms).
- Are willing to stop taking all anti-HIV drugs except study drugs. (Patients may be able to continue taking drugs for other infections.)
Who cannot join
- Patients will not be eligible for this study if they:
- Have cancer, lung disease, severe hepatitis, or active AIDS-related infections. (Certain AIDS-related infections such as Kaposi's sarcoma may be allowed).
- Have ever taken 3TC, abacavir (ABC), or a protease inhibitor (such as IDV or RTV).
- Have changed their medications in the last 2 weeks.
- Are allergic to IDV, RTV, d4T, or 3TC.
- Have used certain medications (see the technical summary for more detail).
- Are pregnant or breast-feeding.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
CRI New England
Brookline, Massachusetts, 02146
SUNY Health Sciences Ctr
Brooklyn, New York, 11203
AIDS Research Alliance - Chicago
Chicago, Illinois, 60657
Univ of Texas / Thomas Street Clinic
Houston, Texas, 77030
Univ of Miami School of Medicine
Miami, Florida, 33136
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112
Chelsea Village Med Ctr
New York, New York, 10014
Liberty Med Group
New York, New York, 10016
St Lukes / Roosevelt Hosp / HIV Center
New York, New York, 10019
Mount Sinai Med Ctr
New York, New York, 10029
Mark Watkins
Philadelphia, Pennsylvania, 19107
Apogee Med Group
San Diego, California, 92101
Univ of California at San Francisco Gen Hosp
San Francisco, California, 94110
HIV Institute / Davies Med Ctr
San Francisco, California, 94114
Kaiser Foundation Hospital
San Francisco, California, 94118
Bronx Lebanon Hosp Ctr
The Bronx, New York, 10456
Montefiore Med Ctr
The Bronx, New York, 10467
About this study
Official title: A Multicenter, Open-Label, 24-Week Pilot Study to Evaluate the Safety and Efficacy of Indinavir Sulfate 800 Mg b.i.d. in Combination With Ritonavir 100 Mg/d4T/3TC b.i.d. in HIV-Infected Individuals
The purpose of this study is to see whether taking indinavir (IDV) plus ritonavir (RTV) plus stavudine (d4T) plus lamivudine (3TC) 2 times each day is safe and can lower the level of HIV in the blood.
Read the detailed description
Patients take IDV plus RTV plus d4T plus 3TC twice daily for 24 weeks. Every 4 weeks, patients have physical exams and laboratory tests of blood and urine, and CD4 cell counts and plasma viral RNA are measured. At Week 24, the proportion of patients with plasma viral RNA below 400 copies/ml is determined to identify any clinically meaningful antiretroviral activity for the drug regimen. An observed response proportion of 80% or higher will be considered clinically meaningful.
- Conditions
- HIV Infections
- Being tested
- Indinavir sulfate, Ritonavir, Lamivudine, Stavudine
- Keywords
- Drug Therapy, Combination, Stavudine, HIV Protease Inhibitors, Ritonavir, Lamivudine, Indinavir, 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
RitonavirDrug
LamivudineDrug
StavudineDrug
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
- 80 participants
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002241
- Sponsor's protocol ID
- 246T
- Other IDs
- 094-00, CRX463
- Status last verified
- Jul 2001
- 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, 24-Week Pilot Study to Evaluate the Safety and Efficacy of Indinavir Sulfate 800 Mg b.i.d. in Combination With Ritonavir 100 Mg/d4T/3TC b.i.d. in HIV-Infected Individuals
- ClinicalTrials.gov ID
- NCT00002241
- Acronym / sponsor ID
- 246T
- Conditions
- HIV Infections
- Keywords
- Drug Therapy, Combination, Stavudine, HIV Protease Inhibitors, Ritonavir, Lamivudine, Indinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 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 whether taking indinavir (IDV) plus ritonavir (RTV) plus stavudine (d4T) plus lamivudine (3TC) 2 times each day is safe and can lower the level of HIV in the blood.
Detailed description
Patients take IDV plus RTV plus d4T plus 3TC twice daily for 24 weeks. Every 4 weeks, patients have physical exams and laboratory tests of blood and urine, and CD4 cell counts and plasma viral RNA are measured. At Week 24, the proportion of patients with plasma viral RNA below 400 copies/ml is determined to identify any clinically meaningful antiretroviral activity for the drug regimen. An observed response proportion of 80% or higher will be considered clinically meaningful.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Are HIV-positive.
- Have a CD4 cell count of 75 cells/mm3 or more and a viral load of 5,000 copies/ml or more.
- Are age 16 or older (consent of a parent or guardian required if under 18).
- Agree to practice abstinence or use barrier methods of birth control (such as condoms).
- Are willing to stop taking all anti-HIV drugs except study drugs. (Patients may be able to continue taking drugs for other infections.)
Key exclusion criteria (7 listed)
- Have cancer, lung disease, severe hepatitis, or active AIDS-related infections. (Certain AIDS-related infections such as Kaposi's sarcoma may be allowed).
- Have ever taken 3TC, abacavir (ABC), or a protease inhibitor (such as IDV or RTV).
- Have changed their medications in the last 2 weeks.
- Are allergic to IDV, RTV, d4T, or 3TC.
- Have used certain medications (see the technical summary for more detail).
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 | – |
| Lamivudine | Drug | – |
| Stavudine | 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.
18 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, Ritonavir and Lamivudine in people with HIV Infections, run by Merck Sharp & Dohme LLC at 18 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 6 inclusion and 7 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 18 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; AzTrials last refreshed its copy on 8 Nov 2026.