The Safety and Effectiveness of Lamivudine Plus Stavudine or Zidovudine in HIV-Infected Patients Who Have Taken Zidovudine

Completed · Phase 3

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00002371

Run by

Bristol-Myers Squibb

People needed

80

Starts

1996-06-01

Expected to finish

1997-12-01

Last updated by the study team

2011-05-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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:

Where it is running

• Harbor UCLA Med Ctr — Torrance, California, United States
• Univ of South Florida — Tampa, Florida, United States
• SUNY at Stony Brook / Division of Infectious Diseases — Stony Brook, New York, United States
• Houston Clinical Research Network / Div of Montrose Clinic — Houston, Texas, United States
• Univ of Utah / School of Medicine / Div of Infect Dis — Salt Lake City, Utah, United States
• Sunnybrook Health Science Ctr — North York, Ontario, Canada
• Montreal Gen Hosp / Div of Clin Immuno and Allergy — Montreal, Quebec, Canada
• Univ of Puerto Rico School of Medicine — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.