Safety and Effectiveness of Lamivudine When Given Once a Day Versus Twice a Day in Combination With Other Anti-HIV Drugs in HIV-Infected Adults Who Have Never Received Anti-HIV Drugs - Full Text View

Purpose

The purpose of this study is to look at the safety and effectiveness of receiving lamivudine (3TC) once a day versus twice a day as part of an anti-HIV drug combination.

Condition	Intervention	Phase
HIV Infections	Drug: Efavirenz Drug: Lamivudine Drug: Zidovudine	Phase 2


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Phase II/III 48-Week, Randomized, Double-Blind, Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Lamivudine 300mg Once Daily Vs. Lamivudine 150mg BID in Combination With Zidovudine 300mg BID and Efavirenz 600mg Once Daily in Antiretroviral-Naive Adults With HIV-1 Infection

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS HIV/AIDS Medicines

Drug Information available for: Zidovudine Lamivudine Efavirenz

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:


Study Start Date:	September 1999

Detailed Description:

Patients are randomized to receive the same total dosage of 3TC either twice a day (Group 1) or once a day (Group 2) in combination with ZDV and EFV over 48 weeks. Viral load measurements will be performed at Weeks 4, 8, 12, 16, 20, 24, and every 8 weeks thereafter.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

Are 18 years of age or older.
Are HIV-positive.
Have a viral load (level of HIV in the blood) of at least 400 copies/ml within 21 days of study entry.
Have a CD4 count greater than 100 cells/mm3 within 21 days of study entry.
Agree to practice abstinence or use effective barrier methods of birth control (or, if patient is a woman, unable to have children).

Exclusion Criteria

Patients will not be eligible for this study if they:

Have taken any antiretroviral (anti-HIV) agent.
Are pregnant or breast-feeding.
Are unable to absorb food or have trouble taking medicines by mouth.
Abuse alcohol or drugs to an extent that may make study participation difficult.
Are not likely to be able to complete the 48 weeks of study treatment.
Have a history of pancreatitis (inflamed pancreas) or hepatitis within the last 6 months or any evidence of liver disease.
Have received an investigational vaccine within the past 3 months or have received gene therapy.
Have a severe medical condition such as diabetes or heart trouble.
Have been diagnosed with AIDS.
Have had radiation therapy or chemotherapy within 30 days of study entry, except for treatment of Kaposi's sarcoma.
Are taking medications that affect the immune system within 30 days of study entry.
Are taking medications that may interact with the study drugs.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004852

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Sponsors and Collaborators

Glaxo Wellcome

More Information


ClinicalTrials.gov Identifier:	NCT00004852 History of Changes
Other Study ID Numbers:	225D EPV2000 1
Study First Received:	March 2, 2000
Last Updated:	June 23, 2005
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:


HIV-1 Drug Therapy, Combination Zidovudine Drug Administration Schedule Lamivudine Genotype	Phenotype Reverse Transcriptase Inhibitors Anti-HIV Agents Viral Load efavirenz

Additional relevant MeSH terms:


Infection HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Lamivudine Zidovudine Efavirenz Reverse Transcriptase Inhibitors	Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Anti-HIV Agents Antimetabolites Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 Enzyme Inhibitors Cytochrome P-450 CYP2C19 Inhibitors Cytochrome P-450 CYP2B6 Inducers Cytochrome P-450 Enzyme Inducers Cytochrome P-450 CYP3A Inducers

ClinicalTrials.gov processed this record on September 28, 2016