Clinical trial NCT00002371: The Safety and Effectiveness of Lamivudine Plus Stavudine or Zidovudine in HIV-Infected Patients Who Have Taken Zidovudine
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Keywords: HIV-1
Drug Therapy, Combination
Stavudine
Lamivudine
RNA, Viral
Anti-HIV Agents
Viral Load
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Torrance
country: United States
facility: Harbor UCLA Med Ctr
state: California
city: Tampa
country: United States
facility: Univ of South Florida
state: Florida
city: Stony Brook
country: United States
facility: SUNY at Stony Brook / Division of Infectious Diseases
state: New York
city: Houston
country: United States
facility: Houston Clinical Research Network / Div of Montrose Clinic
state: Texas
city: Salt Lake City
country: United States
facility: Univ of Utah / School of Medicine / Div of Infect Dis
state: Utah
city: North York
country: Canada
facility: Sunnybrook Health Science Ctr
state: Ontario
city: Montreal
country: Canada
facility: Montreal Gen Hosp / Div of Clin Immuno and Allergy
state: Quebec
city: San Juan
country: Puerto Rico
facility: Univ of Puerto Rico School of Medicine
Study officials:
References: