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

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Completed

CT.gov ID

NCT00002371

Collaborator

(none)

Enrollment

Locations

Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Indinavir sulfate Drug: Lamivudine Drug: Stavudine Drug: Zidovudine	Phase 3

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

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 Start Date :

Jun 1, 1996

Actual Primary Completion Date :

Dec 1, 1997

Actual Study Completion Date :

Dec 1, 1997

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Harbor UCLA Med Ctr	Torrance	California	United States	90502
2	Univ of South Florida	Tampa	Florida	United States	33612
3	SUNY at Stony Brook / Division of Infectious Diseases	Stony Brook	New York	United States	11794
4	Houston Clinical Research Network / Div of Montrose Clinic	Houston	Texas	United States	77006
5	Univ of Utah / School of Medicine / Div of Infect Dis	Salt Lake City	Utah	United States	84132
6	Sunnybrook Health Science Ctr	North York	Ontario	Canada
7	Montreal Gen Hosp / Div of Clin Immuno and Allergy	Montreal	Quebec	Canada
8	Univ of Puerto Rico School of Medicine	San Juan		Puerto Rico	00927