Four-Drug Combination Therapy With Zidovudine, Lamivudine, 1592U89 (Abacavir), and 141W94 (Amprenavir) in HIV-Infected Patients
Information source: National Institute of Allergy and Infectious Diseases (NIAID)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Abacavir sulfate (Drug); Amprenavir (Drug); Lamivudine (Drug); Zidovudine (Drug)
Phase: N/A
Status: Active, not recruiting
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID) Official(s) and/or principal investigator(s):
Martin Markowitz, Principal Investigator
Summary
The purpose of this study is to see if the multidrug combination of zidovudine (ZDV),
lamivudine (3TC), 1592U89 (abacavir [ABC]), and 141W94 (amprenavir [APV]) is a safe and
effective treatment for HIV-infected patients and if there is a reduction of active HIV in
blood and other tissues.
HIV infection is a life-changing illness and new HIV treatments must be tested. This study
will test if a 4-drug combination will reduce HIV virus activity in blood and other tissues
and if it is safe and well tolerated. Doctors also want to know if the multidrug combination
is able to decrease viral activity over a long time period.
Clinical Details
Official title: An Open-Label, Single Center Trial to Evaluate the Efficacy and Safety of Quadruple Chemotherapy (Zidovudine, EPIVIR, 1592U89, and 141W94) in Subjects Infected With HIV-1 (GW QUAD)
Study design: Treatment, Open Label, Safety Study
Detailed description:
With effective combination ART, there is a decrease in HIV-1 RNA in plasma after 2 to 3
weeks. A second, slower phase of viral decay is thought to occur in long-lived macrophages,
with a minimal contribution from lymphocytes. This study addresses whether there is a third
reservoir such as the central nervous system. Additionally, the study aims to provide a
better understanding of the type and length of ART required to suppress HIV-1 replication in
multiple reservoirs.
Patients receive treatment with ZDV, 3TC, ABC, and APV daily for 24 weeks. Clinic visits
occur weekly until Week 4, then every 2 weeks until Week 12, then monthly. Blood and urine
samples are collected and patients are monitored for clinical or laboratory abnormalities.
Laboratory tests to assess side effects and virologic and immunologic parameters, including
viral quantification of CSF on all chronically infected patients and selected consenting
acutely infected patients, are determined. In a pharmacoeconomic component of this study,
patients have interviews and complete questionnaires at 5 clinic visits.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria
Patients may be eligible for this study if they:
- Are at least 18 years old.
- Have a chronic (long-term) HIV infection (greater than 90 days) or a recent HIV
infection.
- Have a plasma viral load (level of HIV in the blood) of at least 5,000 copies/ml (for
chronically infected patients only).
- Are able to follow study requirements.
- Agree to practice reliable forms of birth control such as barrier or surgical methods,
starting 1 month prior to entry and while enrolled in the study.
Exclusion Criteria
Patients will not be eligible for this study if they:
- Have had prior anti-HIV treatment (for recently infected patients only).
- Have a history of blood-clotting problems.
- Have ever received treatment with protease inhibitors or 3TC.
- Are at high risk for developing an infection in the heart.
- Are critically ill.
- Are mentally disabled, a prisoner, or confined in an institution.
- Are breast-feeding or pregnant.
- Have gastrointestinal problems that might interfere with drug absorption or are unable
to take medicines by mouth.
- Need regular blood transfusions.
- Have had an unexplained fever higher than 38. 5 C for more than 14 days within 30 days
of enrollment.
- Have an opportunistic (AIDS-related) infection that requires treatment (treatment must
be completed 30 days before the start of the study).
- Are taking certain medications that may interfere with the study.
Locations and Contacts
Aaron Diamond AIDS Res Ctr, New York, New York 10016, United States
Additional Information
Click here for more information about Zidovudine Click here for more information about Lamivudine Click here for more information about Abacavir sulfate Click here for more information about Amprenavir Haga clic aquí para ver información sobre este ensayo clínico en español.
Last updated: June 23, 2005
|
