The Effectiveness of Indinavir Plus Zidovudine Plus Lamivudine in HIV-Infected Patients With No Symptoms of Infection
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Indinavir sulfate (Drug); Lamivudine (Drug); Zidovudine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Merck
Summary
To evaluate the ability of the combination of indinavir, zidovudine, and lamivudine to
suppress HIV-1 infection as measured by: (1) the maintenance of HIV-1 serum viral RNA below
the limit of detection of the most sensitive validated assay (ultradirect assay) and (2)
absence of evidence of infectious virus in lymph node, cerebrospinal fluid (CSF), peripheral
mononuclear cells (PBMCs), and semen.
It is hypothesized that the administration of indinavir, zidovudine, and lamivudine will
result in:
1. No evidence of infectious virus in lymph node tissue, CSF, PBMCs, and semen samples in
50% of patients who have undetectable viral RNA by the most sensitive validated assay
available (ultradirect assay) for at least 48 weeks.
2. Sustained suppression of HIV-1 infection as measured by a decrease in serum viral RNA to
below the limit of detection of the ultradirect assay for at least 48 weeks in at least
25% of patients.
3. Suppression of HIV-1 infection as measured by a decrease in serum viral RNA to below the
limit of detection of the standard Amplicor assay (i. e., negative) in at least 90% of
patients by Week 16.
4. Suppression of HIV-1 infection, suggesting eradication of the virus as measured by
maintenance of serum viral RNA to below the limit of detection of the ultradirect assay
for at least 24 weeks after discontinuation of indinavir, zidovudine, and lamivudine in
patients who have maintained this level of suppression for at least 120 weeks on
therapy.
Clinical Details
Official title: A Multiclinic, Open Study to Evaluate the Ability of the Combination of Indinavir, Zidovudine and Lamivudine to Result in Sustained Suppression of HIV-1 in Asymptomatic HIV-1 Seropositive Patients
Study design: Treatment, Efficacy Study
Detailed description:
It is hypothesized that the administration of indinavir, zidovudine, and lamivudine will
result in:
1. No evidence of infectious virus in lymph node tissue, CSF, PBMCs, and semen samples in
50% of patients who have undetectable viral RNA by the most sensitive validated assay
available (ultradirect assay) for at least 48 weeks.
2. Sustained suppression of HIV-1 infection as measured by a decrease in serum viral RNA to
below the limit of detection of the ultradirect assay for at least 48 weeks in at least
25% of patients.
3. Suppression of HIV-1 infection as measured by a decrease in serum viral RNA to below the
limit of detection of the standard Amplicor assay (i. e., negative) in at least 90% of
patients by Week 16.
4. Suppression of HIV-1 infection, suggesting eradication of the virus as measured by
maintenance of serum viral RNA to below the limit of detection of the ultradirect assay
for at least 24 weeks after discontinuation of indinavir, zidovudine, and lamivudine in
patients who have maintained this level of suppression for at least 120 weeks on
therapy.
All patients receive indinavir plus zidovudine plus lamivudine for at least 96 weeks. If
there is no evidence of infectious virus, and patients continue to have serum viral RNA
levels below the limit of detection of the ultradirect assay for at least 96 weeks, therapy
is continued for an additional 24 weeks. However, during this additional 24 weeks of therapy
patients may continue to receive this triple combination drug regimen or make changes to this
drug regimen treatment by reducing their number of antiretroviral agents. After 120 weeks, if
patients continue to have serum viral RNA levels below the limit of detection of the
ultradirect assay, patients discontinue all antiretroviral therapy. However, if there is any
evidence of infectious virus, as outlined above, patients do not discontinue therapy.
Patients who develop detectable serum viral RNA following discontinuation of therapy are
given the option to reinitiate therapy with the triple combination of indinavir, zidovudine
and lamivudine. NOTE: Patients who develop an intolerance to zidovudine may use stavudine at
doses per body weight at the direction of the investigator.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria
Patients must have:
- HIV-1 seropositive status.
- CD4 count >= 500 cells/mm3.
- Serum viral RNA level > 1000 copies/ml.
Exclusion Criteria
Prior Medication:
Excluded:
Previous antiretroviral therapy.
Locations and Contacts
Univ of Alabama at Birmingham, Birmingham, Alabama 352942050, United States
Saint Paul's Hosp, Vancouver, British Columbia, Canada
LAC - USC Med Ctr, Los Angeles, California 90033, United States
AIDS Community Research Consortium, Redwood City, California 94063, United States
San Francisco Gen Hosp, San Francisco, California 94110, United States
Yale Univ School of Medicine / AIDS Program, New Haven, Connecticut 06510, United States
Rush Presbyterian - Saint Luke's Med Ctr / Infect Dis, Chicago, Illinois 606123832, United States
Johns Hopkins Hosp, Baltimore, Maryland 21287, United States
Harvard (Massachusetts Gen Hosp), Boston, Massachusetts 02114, United States
Beth Israel Deaconess Med Ctr - East Campus, Boston, Massachusetts 02215, United States
Brigham and Women's Hosp, Boston, Massachusetts 02115, United States
Fenway Community Health Ctr, Boston, Massachusetts 02115, United States
NYU Med Ctr, New York, New York 10016, United States
Univ Hosp / SUNY at Stony Brook / AIDS TMT Unit, Stony Brook, New York 117948153, United States
Pitt Treatment Ctr, Pittsburgh, Pennsylvania 15213, United States
Montreal Gen Hosp, Montreal, Quebec, Canada
Brown Univ / Miriam Hosp, Providence, Rhode Island 02906, United States
Additional Information
Last updated: June 23, 2005
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