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

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

Sponsors

Lead sponsor: Bristol-Myers Squibb

Source Bristol-Myers Squibb
Brief 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.

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.

Overall Status Completed
Start Date June 1996
Completion Date December 1997
Primary Completion Date December 1997
Phase Phase 3
Study Type Interventional
Enrollment 80
Condition
Intervention

Intervention type: Drug

Intervention name: Indinavir sulfate

Intervention type: Drug

Intervention name: Lamivudine

Intervention type: Drug

Intervention name: Stavudine

Intervention type: Drug

Intervention name: Zidovudine

Eligibility

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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Location
facility
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
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
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, 00927, Puerto Rico
Location Countries

Canada

Puerto Rico

United States

Verification Date

April 2011

Keywords
Condition Browse
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Double

Source: ClinicalTrials.gov