Safety and Effectiveness of Three Anti-HIV Drugs Combined in One Pill (Trizivir)
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ClinicalTrials.gov Identifier: NCT00004981 |
Recruitment Status : Unknown
Verified June 2001 by NIH AIDS Clinical Trials Information Service.
Recruitment status was: Active, not recruiting
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Abacavir sulfate, Lamivudine and Zidovudine Drug: Lamivudine/Zidovudine Drug: Abacavir sulfate | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 230 participants |
Primary Purpose: | Treatment |
Official Title: | A Phase IIIB Randomized, Multicenter Study of the Efficacy and Safety of Combivir 1 Tablet Po Bid Plus Ziagen 300mg Po Bid Versus an Abacavir 300mg/Lamivudine 150mg/Zidovudine 300mg Combination Tablet Po Bid, Administered for 24 Weeks in Subjects With HIV-1 Infection |

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients may be eligible for this study if they:
- Are at least 18 years old.
- Are HIV-positive.
- Are currently receiving one of the following anti-HIV drug combinations: Combivir plus abacavir, Combivir plus abacavir plus a protease inhibitor, or Combivir plus abacavir plus a non-nucleoside reverse transcriptase inhibitor (NNRTI). Patients must have been taking this drug combination for at least the past 16 weeks. This also must be the first anti-HIV drug combination the patient has received.
- Have a viral load (level of HIV in the blood) less than or equal to 400 copies/ml.
- Have CD4+ cell count greater than 200 cells/mm3.
- Agree to use effective methods of birth control.
Exclusion Criteria
Patients will not be eligible for this study if they:
- Have been diagnosed with AIDS.
- Have a gastrointestinal disorder that makes it difficult for patients to absorb food or to take medications by mouth.
- Have hepatitis.
- Have a serious medical condition, such as diabetes, congestive heart failure, or other heart disease.
- Are allergic to any of the study drugs.
- Abuse alcohol or drugs.
- Will not be available for the entire 24-week study period.
- Are pregnant or breast-feeding.
- Have taken or will need to take certain medications, including radiation therapy, chemotherapy, drugs that affect the immune system (such as interleukin), an HIV vaccine, foscarnet, and hydroxyurea.
- Are enrolled in another experimental drug study.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004981

ClinicalTrials.gov Identifier: | NCT00004981 |
Other Study ID Numbers: |
308A ESS40005 |
First Posted: | August 31, 2001 Key Record Dates |
Last Update Posted: | June 24, 2005 |
Last Verified: | June 2001 |
Drug Therapy, Combination Zidovudine Drug Administration Schedule Lamivudine RNA, Viral |
Reverse Transcriptase Inhibitors Anti-HIV Agents Viral Load Combivir abacavir |
Infections Lamivudine Zidovudine Abacavir Dideoxynucleosides Lamivudine, zidovudine drug combination Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Anti-HIV Agents Anti-Retroviral Agents Antimetabolites |