The Safety and Effectiveness of Three Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Taken AZT

Completed · Phase 3

Conditions studied: HIV Infections

In brief

To evaluate the safety and efficacy of low and high doses of lamivudine ( 3TC ) in combination with zidovudine ( AZT ) and zalcitabine ( dideoxycytidine; ddC ) in combination with AZT. PER 02/27/95 AMENDMENT: To evaluate the efficacy and safety of both blinded and open-label combination therapy.

Key facts

Study ID

NCT00002436

Run by

Glaxo Wellcome

People needed

325

Last updated by the study team

2005-06-24

Who can join

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

You may qualify if…

• Patients must have:
• HIV positivity.
• CD4 count 100-300 cells/mm3.
• Prior AZT therapy for 24 or more weeks and currently on AZT.

You may not qualify if…

• Patients with the following prior conditions are excluded:
• History of intolerance to AZT.
• History of grade 2 or worse peripheral neuropathy.
• Prior Medication:
• Excluded:
• Any prior antiretroviral therapy other than AZT.
• Required:
• Concomitant AZT therapy.
• Required:
• At least 24 weeks of prior AZT.

Where it is running

• Combat Group — Los Angeles, California, United States
• San Diego Community Research Group — San Diego, California, United States
• ViRx Inc — San Francisco, California, United States
• AIDS Research Consortium of Atlanta — Atlanta, Georgia, United States
• Chicago Ctr for Clinical Research — Chicago, Illinois, United States
• Louisiana Cardiovascular Research Ctr — New Orleans, Louisiana, United States
• Boston City Hosp / FGH-1 — Boston, Massachusetts, United States
• Nassau County Med Ctr — East Meadow, New York, United States
• Saint Luke's - Roosevelt Hosp Ctr — New York, New York, United States
• Nalle Clinic — Charlotte, North Carolina, United States
• Duke Univ Med Ctr — Durham, North Carolina, United States
• Portland Veterans Adm Med Ctr / Rsch & Education Grp — Portland, Oregon, United States
• Milton S Hershey Med Ctr — Hershey, Pennsylvania, United States
• Central Texas Med Foundation — Austin, Texas, United States
• Univ of Texas Southwestern Med Ctr of Dallas — Dallas, Texas, United States
• Nicholaos Bellos — Dallas, Texas, United States
• Houston Clinical Research Network — Houston, Texas, United States
• Wisconsin Community - Based Research Consortium — Milwaukee, Wisconsin, United States
• Ottawa General Hospital — Ottawa, Ontario, Canada
• Toronto Hosp — Toronto, Ontario, Canada
• Montreal Gen Hosp — Montreal, Quebec, Canada
• Hosp Regional de Ponce - Area Vieja — Ponce, Puerto Rico

Full record on ClinicalTrials.gov

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