Oakland, California 94609

  • HIV Infections

Purpose:

The purpose of this study is to look at the safety and effectiveness of a pill called Trizivir that is a combination of three anti-HIV drugs (zidovudine, lamivudine, and abacavir). Zidovudine and lamivudine are often given combined in one pill (Combivir). In this study, Trizivir will be compared to Combivir plus abacavir.


Study summary:

Patients are randomized to receive either the triple combination tablet (Trizivir) or to receive Combivir plus abacavir as a separate tablet. Patients take their study medications for 24 weeks.


Criteria:

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.


Study is Available At:


Original ID:

308A


NCT ID:

NCT00004981


Secondary ID:

ESS40005


Study Acronym:


Brief Title:

Safety and Effectiveness of Three Anti-HIV Drugs Combined in One Pill (Trizivir)


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


Overall Status:

Active, not recruiting


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

NIH AIDS Clinical Trials Information Service


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Safety Study, Primary Pu


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

230


Enrollment Type:


Study Dates

Verification Date:June 2001
Last Changed Date:June 23, 2005
First Received Date:March 13, 2000

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:Abacavir sulfate, Lamivudine and Zidovudine
Intervention Type:Drug
Name:Lamivudine/Zidovudine
Intervention Type:Drug
Name:Abacavir sulfate

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Glaxo Wellcome

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


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