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A Study of the Safety and Effectiveness of Combination Anti-HIV Therapy in HIV-Infected Adults

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Abacavir sulfate, Lamivudine and Zidovudine
Lamivudine/Zidovudine
Abacavir sulfate
Efavirenz
Sponsored by
Glaxo Wellcome
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Drug Therapy, Combination, Zidovudine, Lamivudine, RNA, Viral, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load, abacavir, efavirenz

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Patients may be eligible for this study if they: Are HIV-positive. Have HIV levels of 50,000 copies/ml or more within 21 days prior to starting treatment. Are at least 18 years of age. Are willing to use an effective method of birth control during the study. (This study has been changed. A CD4 cell count of 50/mm3 or more within 21 days prior to starting treatment is no longer required.) Exclusion Criteria Patients will not be eligible for this study if they: Are pregnant. Have AIDS. Cannot take medications by mouth. Have hepatitis and it is active. Are enrolled in other investigational drug studies. Are allergic to any of the study drugs. Have a serious medical condition, such as heart disease. Have ever taken certain anti-HIV drugs such as nonnucleoside reverse transcriptase inhibitors (NNRTIs) or protease inhibitors (PIs). Have ever had more than 7 days of treatment with a nucleoside reverse transcriptase inhibitor (NRTI). Patients should have no prior treatment with abacavir and no prior treatment with at least one of the following: lamivudine or zidovudine. Have had radiation therapy or chemotherapy within 4 weeks prior to study entry, or plan to have such therapy during the study. Have received medications that might affect the immune system, such as systemic corticosteroids, interleukins, vaccines, or interferons within 4 weeks prior to study entry. Have received an HIV vaccine within 3 months prior to study entry. Are taking foscarnet, hydroxyurea, or other drugs that work against HIV. Have taken certain medications such as astemizole, cisapride, dihydroergotamine, ergotamine, ganciclovir, interferon-alpha, midazolam, terfenadine, and triazolam within 21 days of study entry. Abuse alcohol or drugs. Are unable to complete the whole study.

Sites / Locations

  • Tower Infectious Diseases / Med Associates Inc
  • George Washington Univ Med Ctr
  • North Shore Univ Hosp
  • Thomas Jefferson Univ
  • Dallas Veterans Administration Med Ctr

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 15, 2000
Last Updated
June 23, 2005
Sponsor
Glaxo Wellcome
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1. Study Identification

Unique Protocol Identification Number
NCT00004585
Brief Title
A Study of the Safety and Effectiveness of Combination Anti-HIV Therapy in HIV-Infected Adults
Official Title
A Phase IV, Open-Label, Multicenter Study of the Efficacy and Safety of Quadruple Combination Antiretroviral Therapy With Combivir (Lamivudine 150mg/Zidovudine 300mg) BID, Ziagen (Abacavir) 300mg BID, and Sustiva (Efavirenz) 600mg QD for 24 Weeks, Followed by the Triple Nucleoside Combination Tablet (Abacavir 300mg/Lamivudine 150mg/Zidovudine 300mg) BID Plus Sustiva (Efavirenz) 600mg QD for 24 Weeks in HIV-Infected Adults
Study Type
Interventional

2. Study Status

Record Verification Date
November 2000
Overall Recruitment Status
Completed
Study Start Date
October 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Glaxo Wellcome

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to see if a certain combination of anti-HIV drugs is safe and effective in HIV-infected patients. The drug combination includes a tablet containing lamivudine and zidovudine (called Combivir) plus abacavir plus efavirenz.
Detailed Description
Patients take open-label Combivir plus abacavir plus efavirenz for 48 weeks. [AS PER AMENDMENT 4/20/00: Patients taking Combivir plus abacavir at Week 24 receive the triple-nucleoside-combination tablet (TCT) (abacavir/lamivudine/zidovudine) beginning at Week 24 and continuing through Week 48, in combination with efavirenz (or nevirapine if the patient has made a protocol-allowed substitution). Patients not taking Combivir and abacavir at Week 24 will continue in the study on the substituted protocol-allowed drug regimen, provided their plasma HIV RNA is below 400 copies/ml at 24 weeks.] Following enrollment on Study Day 1, on-study evaluations (virologic and safety) are performed at Weeks 2, 4, 8, 12, 16, and then every 8 weeks through Week 48 (end of study). CD4 evaluations are performed at baseline and at Weeks 4, 8, and then every 8 weeks through Week 48. Immune reconstitution testing is performed at baseline and at Weeks 12, 24, and 48. Patients complete the PMAQ7 version 1.1 medication adherence questionnaire at Weeks 2, 8, 12, 24, and 48 (or at their last study visit). All patients are requested to return for a post-study follow-up evaluation 2 to 4 weeks after the last on-study visit. Patients must have a plasma HIV RNA less than 400 copies/ml at Week 24 in order to continue in the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Drug Therapy, Combination, Zidovudine, Lamivudine, RNA, Viral, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load, abacavir, efavirenz

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Enrollment
40 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Abacavir sulfate, Lamivudine and Zidovudine
Intervention Type
Drug
Intervention Name(s)
Lamivudine/Zidovudine
Intervention Type
Drug
Intervention Name(s)
Abacavir sulfate
Intervention Type
Drug
Intervention Name(s)
Efavirenz

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Patients may be eligible for this study if they: Are HIV-positive. Have HIV levels of 50,000 copies/ml or more within 21 days prior to starting treatment. Are at least 18 years of age. Are willing to use an effective method of birth control during the study. (This study has been changed. A CD4 cell count of 50/mm3 or more within 21 days prior to starting treatment is no longer required.) Exclusion Criteria Patients will not be eligible for this study if they: Are pregnant. Have AIDS. Cannot take medications by mouth. Have hepatitis and it is active. Are enrolled in other investigational drug studies. Are allergic to any of the study drugs. Have a serious medical condition, such as heart disease. Have ever taken certain anti-HIV drugs such as nonnucleoside reverse transcriptase inhibitors (NNRTIs) or protease inhibitors (PIs). Have ever had more than 7 days of treatment with a nucleoside reverse transcriptase inhibitor (NRTI). Patients should have no prior treatment with abacavir and no prior treatment with at least one of the following: lamivudine or zidovudine. Have had radiation therapy or chemotherapy within 4 weeks prior to study entry, or plan to have such therapy during the study. Have received medications that might affect the immune system, such as systemic corticosteroids, interleukins, vaccines, or interferons within 4 weeks prior to study entry. Have received an HIV vaccine within 3 months prior to study entry. Are taking foscarnet, hydroxyurea, or other drugs that work against HIV. Have taken certain medications such as astemizole, cisapride, dihydroergotamine, ergotamine, ganciclovir, interferon-alpha, midazolam, terfenadine, and triazolam within 21 days of study entry. Abuse alcohol or drugs. Are unable to complete the whole study.
Facility Information:
Facility Name
Tower Infectious Diseases / Med Associates Inc
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
George Washington Univ Med Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
North Shore Univ Hosp
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Thomas Jefferson Univ
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Dallas Veterans Administration Med Ctr
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States

12. IPD Sharing Statement

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A Study of the Safety and Effectiveness of Combination Anti-HIV Therapy in HIV-Infected Adults

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