A Comparison of Lamivudine and Zidovudine, Used Alone and Together, in HIV-Infected Patients Who Have Not Used Zidovudine in the Past

Completed · Phase 3

Conditions studied: HIV Infections

In brief

To evaluate the safety and efficacy of high-dose lamivudine (3TC) alone versus zidovudine (AZT) alone versus 3TC at high and low doses in combination with AZT in HIV-1 infected patients. PER 02/27/95 AMENDMENT: To evaluate the efficacy and safety of both blinded and open-label combination therapy.

Key facts

Study ID

NCT00002320

Run by

Glaxo Wellcome

People needed

320

Last updated by the study team

2005-12-12

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have:
• HIV positivity.
• CD4 count 200-500 cells/mm3.
• AZT naive status (<= 4 weeks of prior AZT).

You may not qualify if…

• Patients with the following prior condition are excluded:
• History of intolerance to AZT.
• Prior Medication:
• Excluded:
• More than 4 weeks of prior AZT.
• Any prior antiretroviral treatment other than AZT.

Where it is running

• Combat Group — Los Angeles, California, United States
• San Diego Community Research Group — San Diego, California, United States
• Pacific Oaks Med Group — Sherman Oaks, California, United States
• Harbor - UCLA Med Ctr — Torrance, California, United States
• Infectious Disease Research Institute Inc — Tampa, Florida, 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
• CRI of New England — Brookline, Massachusetts, United States
• Saint Luke's - Roosevelt Hosp Ctr — New York, New York, United States
• Univ of North Carolina School of Medicine — Chapel Hill, North Carolina, United States
• Med College of Ohio — Toledo, Ohio, United States
• Portland Veterans Adm Med Ctr / Rsch & Education Grp — Portland, Oregon, United States
• Mem Hosp of Rhode Island — Pawtucket, Rhode Island, United States
• Central Texas Med Foundation — Austin, Texas, United States
• Nicholaos Bellos — Dallas, Texas, United States
• Richmond AIDS Consortium — Richmond, Virginia, 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
• Advance Community Health Services Inc — Santurce, Puerto Rico

Full record on ClinicalTrials.gov

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