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
This study has been completed.
Sponsor:
Glaxo Wellcome
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00004852
First received: March 2, 2000
Last updated: June 23, 2005
Last verified: August 2000
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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:
Further study details as provided by NIH AIDS Clinical Trials Information Service:
| Study Start Date: | September 1999 |
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 |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004852
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Show 66 Study LocationsSponsors and Collaborators
Glaxo Wellcome
More Information
No publications provided
| 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:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Zidovudine Lamivudine |
Reverse Transcriptase Inhibitors Efavirenz Anti-HIV Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013