A Study of the Safety and Effectiveness of Combination Anti-HIV Therapy in HIV-Infected Adults
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Abacavir sulfate, Lamivudine and Zidovudine (Drug); Lamivudine/Zidovudine (Drug); Abacavir sulfate (Drug); Efavirenz (Drug)
Phase: Phase 4
Sponsored by: Glaxo Wellcome
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.
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 design: Treatment, Safety Study
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.
Minimum age: 18 Years.
Maximum age: N/A.
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
- 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.)
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
- 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.
Locations and Contacts
Tower Infectious Diseases / Med Associates Inc, Los Angeles, California 90048, United States
George Washington Univ Med Ctr, Washington, District of Columbia 20037, United States
North Shore Univ Hosp, Manhasset, New York 11030, United States
Thomas Jefferson Univ, Philadelphia, Pennsylvania 19107, United States
Dallas Veterans Administration Med Ctr, Dallas, Texas 75216, United States
Starting date: October 1999
Last updated: June 23, 2005