HIV InfectionsPhase 3NCT00002410

A Study of Three Different Anti-HIV Drug Combinations in HIV-Infected Patients

A Phase 3 study testing Indinavir sulfate, Lamivudine and Zidovudine in people with HIV Infections, run by Dupont Merck at 41 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to compare the safety and effectiveness of three anti-HIV drug combinations. The three combinations are: (1) efavirenz (DMP 266) plus indinavir; (2) DMP 266 plus zidovudine (ZDV) plus lamivudine (3TC); and (3) indinavir plus ZDV plus 3TC. Read more about this study

Who is it for?: Ages 13 to 60 years
Conditions the study is for: HIV Infections
What is being tested?: Indinavir sulfate, Lamivudine and Zidovudine
How many people: Not given
Where: 41 sitesin 2 countries
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 13 to 60 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

None listed.

Who cannot join

Concurrent Medication:
Excluded:
Terfenadine, astemizole, cisapride, triazolam, or midazolam (competition for the enzyme cytochrome P-450 3A4 [CYP3A4] by indinavir could result in inhibition of metabolic breakdown of these drugs and create the potential for serious and/or life threatening events [i.e., cardiac arrhythmia, prolonged sedation]).
Rifampin or rifabutin (prohibited because of potential drug interaction with indinavir).
Ketoconazole, itraconazole, and clarithromycin.
Concomitant systemic therapy for acute opportunistic infection or malignancy.

Show all 18Show fewer

Excluded:
Life expectancy less than 12 months.
Prior Medication:
Excluded:
Prior treatment with efavirenz, 3TC, an NNRTI, or an HIV protease inhibitor.
Prior antiretroviral agent within 14 days of initiating study treatment.
Prior treatment (within 30 days of initiating study treatment) with any other experimental drug for any indication.
Patients must:
Have a diagnosis of HIV infection.
Have CD4 counts greater than or equal to 50 cell/mm3.
Have a life expectancy greater than or equal to 12 months.
Be post-pubescent.

Trial locations and contacts

41 sites in 2 countries.

Country

City, postcode or hospital

41 sites in 2 countries

United States40 sites

Georgia Research Associates
Atlanta, Georgia, 30342
Med College of Georgia
Augusta, Georgia, 30912
Richard Stryker
Beverly Hills, California, 90210
Bach and Godofsky
Bradenton, Florida, 34205
Remington-Davis Inc
Columbus, Ohio, 43215
Community Research Initiative of South Florida
Coral Gables, Florida, 33146
Research Services 2000 Inc
Dallas, Texas, 75208
Division of Infectious Disease / Dept of Internal Medicine
Dallas, Texas, 752359113
Research Services 2000 Inc
Fort Worth, Texas, 76103
Montrose Clinic
Houston, Texas, 77006
UT-Health Science Ctr
Houston, Texas, 77030
Infectious Diseases
Indianapolis, Indiana, 46202
Paul Cimoch
Irvine, California, 92618
Boulevard Comprehensive Care Ctr
Jacksonville, Florida, 32209
Kansas City AIDS Research Consortium
Kansas City, Missouri, 64111
Larry Marc Bush / c/o Sally Yantis
Lake Worth, Florida, 33463
Univ Med Ctr / HIV Wellness Ctr
Las Vegas, Nevada, 89102
Univ of Kentucky Med Ctr
Lexington, Kentucky, 40536
AIDS Healthcare Foundation
Los Angeles, California, 90027
Kraus Med Group
Los Angeles, California, 90036
Oasis Clinic / Martin Luther Jr Gen Hosp / King-Drew Med Ctr
Los Angeles, California, 90059
Univ of Miami School of Medicine
Miami, Florida, 33136
Infectious Diseases Associates
Milwaukee, Wisconsin, 53215
Community Research Initiative on AIDS
New York, New York, 10001
Clinical Directors Network / HIV/AIDS Program Manager
New York, New York, 10011
Oyster Point Med Specialists
Newport News, Virginia, 23606
Univ of Nebraska Med Ctr / HIV Clinic
Omaha, Nebraska, 681985400
Philadelphia FIGHT
Philadelphia, Pennsylvania, 19107
Phoenix Body Positive
Phoenix, Arizona, 85016
The Miriam Hosp
Providence, Rhode Island, 02906
Diagnostic Clinic of San Antonio
San Antonio, Texas, 78229
Novum Inc / Pharmaceutical Research Services
Seattle, Washington, 98122
Blick Med Associates
Stamford, Connecticut, 06901
Ctr for Quality Care
Tampa, Florida, 33609
Daniel Seekins
Tampa, Florida, 33614
Infectious Disease Research Institute
Tampa, Florida, 33614
Arizona Clinical Research Ctr Inc
Tucson, Arizona, 85712
Treasure Coast Infectious Disease Consultants
Vero Beach, Florida, 32960
Novum Inc
Washington D.C., District of Columbia, 20037
Wake Forest Univ School of Medicine
Winston-Salem, North Carolina, 27157

Other trials in United States

Puerto Rico1 site

Javier O Morales Ramirez
San Juan, 00909

Other trials in Puerto Rico

About this study

Official title: A Phase III, Multicenter, Randomized, Open-Label Study to Compare Antiretroviral Activity and Tolerability of Three Different Combination Regimens (DMP 266 + Indinavir, DMP 266 + Zidovudine + Lamivudine, Indinavir + Zidovudine + Lamivudine) in HIV-Infected Patients

Conditions: HIV Infections
Being tested: Indinavir sulfate, Lamivudine, Zidovudine
Keywords: HIV-1, Drug Therapy, Combination, Zidovudine, Drug Resistance, Microbial, HIV Protease Inhibitors, Lamivudine, Indinavir, Genotype, Reverse Transcriptase Inhibitors, efavirenz
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
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 3
Primary purpose: Treatment

IDs, dates and publications

ClinicalTrials.gov ID: NCT00002410
Sponsor's protocol ID: 281B
Other IDs: DMP 266-006
Status last verified: Nov 1998
First submitted: 2 Nov 1999
Last updated: 24 Jun 2005
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
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Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder

All HIV Infections trials

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 Phase III, Multicenter, Randomized, Open-Label Study to Compare Antiretroviral Activity and Tolerability of Three Different Combination Regimens (DMP 266 + Indinavir, DMP 266 + Zidovudine + Lamivudine, Indinavir + Zidovudine + Lamivudine) in HIV-Infected Patients
ClinicalTrials.gov ID: NCT00002410
Acronym / sponsor ID: 281B
Conditions: HIV Infections
Keywords: HIV-1, Drug Therapy, Combination, Zidovudine, Drug Resistance, Microbial, HIV Protease Inhibitors, Lamivudine, Indinavir, Genotype
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Lead sponsor: Dupont MerckIndustry (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.

Study design

Primary purpose: Treatment

Who may qualify

Ages: 13 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (0 listed)

Key exclusion criteria (18 listed)

Terfenadine, astemizole, cisapride, triazolam, or midazolam (competition for the enzyme cytochrome P-450 3A4 [CYP3A4] by indinavir could result in inhibition of metabolic breakdown of these drugs and create the potential for serious and/or life threatening events [i.e., cardiac arrhythmia, prolonged sedation]).
Rifampin or rifabutin (prohibited because of potential drug interaction with indinavir).
Ketoconazole, itraconazole, and clarithromycin.
Concomitant systemic therapy for acute opportunistic infection or malignancy.
Life expectancy less than 12 months.

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	–
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.

Related trials for HIV Infections

Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder

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.

41 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Indinavir sulfate, Lamivudine and Zidovudine in people with HIV Infections, run by Dupont Merck at 41 sites in 2 countries.

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 0 inclusion and 18 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 41 sites in United States, Puerto Rico. 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?

On the ClinicalTrials.gov record for NCT00002410.

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.