Early intensification with abacavir in subjects at high risk for incomplete viral suppression.
John A Bartlett, Pablo Tebas, Roland Bassett...
https://pubmed.ncbi.nlm.nih.gov/14518706Completed
Phase 2
Age: 13Years +
All Genders
ID00001132
A Pilot Study of Early Treatment Intensification of Antiretroviral Therapy
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2008-09-09
80
Participants Needed
30
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to see if adding 1 drug to an anti-HIV drug combination early in treatment against HIV can lower the viral load (amount of HIV in the blood) to a level so low that it cannot be measured (undetectable). The drug that will be added to a treatment is abacavir (ABC). Many patients who take 3 anti-HIV drugs together are able to achieve very low viral loads, for example, viral loads below 50 copies/ml. However, some patients taking only 3 drugs are not able to achieve a viral load this low. Doctors hope that, by adding the drug ABC to a current treatment, a viral load below 50 copies/ml can be achieved. Doctors would like to find out if it is effective to start patients on 3 drugs and then add another drug (treatment intensification) if the treatment is not working as well as hoped.
CONDITIONS
Official Title
Effectiveness of the Early Addition of Abacavir to an Anti-HIV Drug Combination
Who Can Participate
Age: 13Years +
All Genders
Eligibility Criteria
You may qualify if you...
Inclusion Criteria
Patients may be eligible for this study if they:
- Are HIV-positive.
- Have been taking anti-HIV therapy that includes at least 3 anti-HIV drugs and is an acceptable anti-HIV drug combination for 60 to 104 days before study treatment. Patients must not have changed any of the drugs in the 28 days before study entry. (This study has been changed by extending the number of days that anti-HIV therapy has been received.)
- Have a viral load greater than 500 but less than or equal to 10,000 copies/ml and have had a significant decrease in viral load between 49 and 84 days after starting this anti-HIV therapy. (This study has been changed by extending the length of time of viral load decrease.)
- Are at least 13 years old (consent of parent or guardian required if under 18).
- Agree to practice abstinence or use barrier method of birth control (such as condoms) during the study and for 3 months after.
Exclusion Criteria
Patients will not be eligible for this study if they:
- Have ever taken ABC.
- Have received anti-HIV therapy for more than 104 days in the past. (This study has been changed by extending the number of days that anti-HIV therapy has been received.)
- Have a fever for 7 days in the 30 days before study entry.
- Have cancer, including Kaposi's sarcoma, that requires chemotherapy.
- Have an active infection that requires treatment in the 21 days before study entry.
- Have any opportunistic (AIDS-related) infection or disease that requires a change in medication in the 14 days before study entry.
- Have any medical condition or history of an illness that the doctor feels would place them at risk or make them unable to complete the study.
- Are taking drugs that affect the immune system or any experimental anti-HIV drugs, except for their current drug combination.
- Are taking St. John's wort. (This study has been changed. Previously, patients taking St. John's wort were eligible.)
- Have received a vaccine in the 21 days before study entry.
- Are pregnant or breast-feeding.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 30 locations
1
UCLA CARE Ctr
Los Angeles, California, United States, 90095
Status Unknown
2
Willow Clinic
Menlo Park, California, United States, 94025
Status Unknown
3
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
San Jose, California, United States, 951282699
Status Unknown
4
San Mateo AIDS Program / Stanford Univ
Stanford, California, United States, 943055107
Status Unknown
5
Stanford Univ Med Ctr
Stanford, California, United States, 943055107
Status Unknown
6
Harbor UCLA Med Ctr
Torrance, California, United States, 90502
Status Unknown
7
Univ of Colorado Health Sciences Ctr
Denver, Colorado, United States, 80262
Status Unknown
8
Univ of Miami School of Medicine
Miami, Florida, United States, 331361013
Status Unknown
9
Emory Univ
Atlanta, Georgia, United States, 30308
Status Unknown
10
Northwestern Univ Med School
Chicago, Illinois, United States, 60611
Status Unknown
11
Cook County Hosp
Chicago, Illinois, United States, 60612
Status Unknown
12
State of MD Div of Corrections / Johns Hopkins Univ Hosp
Baltimore, Maryland, United States, 212052196
Status Unknown
13
Johns Hopkins Hosp
Baltimore, Maryland, United States, 21287
Status Unknown
14
St Louis Regional Hosp / St Louis Regional Med Ctr
St Louis, Missouri, United States, 63112
Status Unknown
15
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, United States, 14215
Status Unknown
16
Beth Israel Med Ctr
New York, New York, United States, 10003
Status Unknown
17
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States, 10016
Status Unknown
18
Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ
New York, New York, United States, 10021
Status Unknown
19
Columbia Presbyterian Med Ctr
New York, New York, United States, 10032
Status Unknown
20
Univ of Rochester Medical Center
Rochester, New York, United States, 14642
Status Unknown
21
Univ of North Carolina
Chapel Hill, North Carolina, United States, 275997215
Status Unknown
22
Duke Univ Med Ctr
Durham, North Carolina, United States, 27710
Status Unknown
23
Univ of Cincinnati
Cincinnati, Ohio, United States, 452670405
Status Unknown
24
Philadelphia Veterans Administration Med Ctr
Philadelphia, Pennsylvania, United States, 19104
Status Unknown
25
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Status Unknown
26
Julio Arroyo
West Columbia, South Carolina, United States, 29169
Status Unknown
27
Vanderbilt Univ Med Ctr
Nashville, Tennessee, United States, 37203
Status Unknown
28
Univ of Texas, Southwestern Med Ctr of Dallas
Dallas, Texas, United States, 75390
Status Unknown
29
Univ of Washington
Seattle, Washington, United States, 98104
Status Unknown
30
Univ of Puerto Rico
San Juan, Puerto Rico, 009365067
Status Unknown
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
N/A
Model
N/A
Primary Purpose
TREATMENT
Number of Arms
0
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