The Safety and Effectiveness of Lamivudine Plus Stavudine or Zidovudine in HIV-Infected Patients Who Have Taken Zidovudine
Information source: Bristol-Myers Squibb
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); Stavudine (Drug); Zidovudine (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Bristol-Myers Squibb Official(s) and/or principal investigator(s):
. ., Principal Investigator, Affiliation: .
Summary
To compare the magnitude and durability of the reduction in plasma HIV RNA in the two
treatment groups over the first 12 weeks of treatment. To determine the safety of each of the
two treatment groups.
Clinical Details
Official title: A Randomized Double-Blind Study of Safety, Virologic and Immunological Effects of Stavudine Plus Lamivudine (3TC) Versus Zidovudine Plus Lamivudine in HIV-Infected Subjects Following At Least Six Months of Zidovudine Therapy
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety Study
Detailed description:
Patients will be randomized to either Stavudine (d4T) + Lamivudine (3TC) + Zidovudine placebo
or Zidovudine (ZDV) + Lamivudine + Stavudine placebo. Patients whose plasma HIV RNA levels
remain >= 500 copies/ml after 8 weeks of blinded double combination therapy will have
indinavir added to their treatment regimen at the week 12 visit.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria
Patients must have:
- At least six months of prior cumulative ZDV therapy.
- Qualifying plasma HIV RNA count of >= 4 log10 copies/ml obtained within 2 weeks of
randomization.
Exclusion Criteria
Co-existing Condition:
Patients with any of the following symptoms or conditions are excluded:
- Presence of newly diagnosed AIDS defining opportunistic infection requiring acute
therapy at time of enrollment.
- Intractable diarrhea (>= 6 loose stools/day for >= 7 consecutive days).
- Signs and symptoms of bilateral peripheral neuropathy >= grade 2 at the time of
screening.
- Inability to tolerate oral medication.
- Any other clinical conditions that in the opinion of the investigator, would make the
patient unsuitable for study or unable to comply with the dosing requirements.
Concurrent Medication:
Excluded:
- Therapy with agents with systemic myelosuppressive, neurotoxic pancreatotoxic,
hepatotoxic or cytotoxic potential.
- Therapy with rifampin, rifabutin, terfenadine, astemizole, cisapride, triazolam,
midazolam and ketoconazole at any time while on indinavir therapy.
Patients with any of the following prior conditions or symptoms are excluded:
- History of acute or chronic pancreatitis.
- Prior history of bilateral peripheral neuropathy.
- Intractable diarrhea (>= 6 loose stools/day for >= 7 consecutive days) within 30 days
prior to study entry.
Prior Medication:
Excluded:
- Any prior antiretroviral therapy except for ddI, ddC, 3TC or ZDV (for ZDV, as
specified in inclusion criteria).
- Previous therapy with agents with significant systemic myelosuppressive, neurotoxic
pancreatotoxic, hepatotoxic or cytotoxic potential within 3 months of study start.
- Therapy with rifampin, rifabutin, terfenadine, astemizole, cisapride, triazolam,
midazolam and ketoconazole within 2 weeks prior to starting indinavir.
- Any other prior therapy that, in the opinion of the investigator, would make the
patient unsuitable for study or unable to comply with the dosing regimen.
Risk Behavior:
Excluded:
- Active alcohol abuse, sufficient in the investigator's opinion, to prevent compliance
with study therapy or to increase the risk of developing pancreatitis.
Required:
At least 6 months of prior cumulative ZDV therapy.
Locations and Contacts
Univ of Puerto Rico School of Medicine, San Juan 00927, Puerto Rico
Harbor UCLA Med Ctr, Torrance, California 90502, United States
Univ of South Florida, Tampa, Florida 33612, United States
SUNY at Stony Brook / Division of Infectious Diseases, Stony Brook, New York 11794, United States
Sunnybrook Health Science Ctr, North York, Ontario, Canada
Montreal Gen Hosp / Div of Clin Immuno and Allergy, Montreal, Quebec, Canada
Houston Clinical Research Network / Div of Montrose Clinic, Houston, Texas 77006, United States
Univ of Utah / School of Medicine / Div of Infect Dis, Salt Lake City, Utah 84132, United States
Additional Information
BMS Clinical Trials Disclosure For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm
Last updated: August 15, 2007
|
