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Home > "A" Clinical Trials Conditions > A Comparison of Two Anti-HIV Treatment Plans  A Comparison of Two Anti-HIV Treatment Plans
A Comparison of Two Anti-HIV Treatment Plans
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: The purpose of this study is to compare 2 treatment plans to try to increase the effects of anti-HIV drugs in patients who are resistant to the drug effects. Sometimes the increase in a patient's viral load (the level of HIV in the blood) can be slowed or stopped by taking anti-HIV drugs. This does not always happen. Sometimes anti-HIV drugs work at first but then stop working. When most of the usual anti-HIV drugs no longer seem to work, the virus is called multidrug-resistant (MDR). This study will compare 2 treatment plans to try to increase the effects of anti-HIV drugs in patients with MDR virus.
Details: An increasing number of patients are developing multidrug-resistant (MDR) virus, as determined by genotypic antiretroviral resistance testing (GART), due to treatment failure to suppress viral replication after several rounds of combination antiretroviral therapy. The best therapeutic strategy for these patients is uncertain. Two strategies currently being used are (1) STI followed by a new antiretroviral regimen and (2) immediate initiation of a new antiretroviral regimen. Patients are screened for the presence of MDR virus and a plasma HIV RNA level greater than 10,000 [AS PER AMENDMENT 07/03/01: greater than 5,000] copies/ml. Eligible patients attend a baseline visit [AS PER AMENDMENT 07/03/01: and a subsequent randomization visit] where the qualifying GART results are provided. Patients who consent to participate have phenotypic antiretroviral resistance testing (PART) done on a specimen from the same blood draw that was used for the GART evaluation. After PART results are available, patients are randomized [AS PER AMENDMENT 07/03/01: If the predicted sensitivities are not available for some or all drugs included in the PART, the patient may still be randomized.] to either a 4-month STI followed by a new antiretroviral regimen or an immediate new antiretroviral regimen. The antiretroviral regimens chosen are based on the patients' history and both GART and PART results. [AS PER AMENDMENT 07/03/01: Additional GART and PART may be requested after at least 4 months of antiretroviral treatment.] Patients have the follow-up data collection done at Months 1-8, 12, and every 4 months thereafter. Changes in antiretroviral therapy, Grade 4 adverse experiences, progression of disease, and deaths are reported as they occur. Patients are seen for clinical management as often as deemed necessary. All patients are followed to a common closing date estimated to be 24 months after the last patient is randomized. Some patients may participate in a Point Mutation Substudy [AS PER AMENDMENT 07/03/01: Plasma Point Mutation Substudy and PBMC Point Mutation Substudy].
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients may be eligible if they: - Have proof of MDR virus from a blood test. - Have a viral load above 5,000 copies/ml from the same blood sample showing MDR virus. - Intend to start a new anti-HIV treatment around the time of the study. - Have been on a stable anti-HIV treatment between 14 days prior to the blood test mentioned above and when they are randomly assigned to a treatment. - Are at least 13 years old (consent of parent or guardian required if under 18). - (This protocol has been changed to reflect new criteria.) Exclusion Criteria Patients will not be eligible if they: - Have received a vaccine or had an illness that might affect viral load within 14 days before the blood test showing MDR virus. - Have received IL-2 within 4 months of the above-mentioned blood test or plan to take IL-2 during the study. - Have an opportunistic (AIDS-related) infection requiring treatment. - Are pregnant or breast-feeding. - Are currently participating in CPCRA 057 (PIP study).
Total Enrollment: 480
Location and Contact Information:
Overall Study Official:
JodyLawrence, Study Chair,
Univ Hosp Infectious Disease
Denver, Colorado, 802044507
United States
Richmond AIDS Consortium / Div of Infect Diseases
Richmond, Virginia, 232980049
United States
Lawrence Goldyn, MD
San Francisco, California, 94110
United States
Henry Ford Hosp
Detroit, Michigan, 48202
United States
Wayne State Univ - WSU/DMC / Univ Hlth Ctr
Detroit, Michigan, 48201
United States
AIDS Research Alliance - Chicago
Chicago, Illinois, 60657
United States
Yale U / New Haven Med Ctr / AIDS Clinical Trials Unit
New Haven, Connecticut, 065102483
United States
Harlem AIDS Treatment Grp / Harlem Hosp Ctr
New York City, New York, 10037
United States
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
New Orleans, Louisiana, 70112
United States
Houston Veterans Administration Med Ctr
Houston, Texas, 77030
United States
Southern New Jersey AIDS Clinical Trials
Camden, New Jersey, 08103
United States
Denver CPCRA / Denver Public Hlth
Denver, Colorado, 802044507
United States
Montrose Clinic
Houston, Texas, 77006
United States
Washington Reg AIDS Prog / Dept of Infect Dis
Washington D.C., District of Columbia, 20422
United States
Community Consortium / UCSF
San Francisco, California, 94110
United States
The Research and Education Group
Portland, Oregon, 97210
United States
Univ TX Health Science Ctr
Houston, Texas, 77030
United States
Our Lady of the Lake Regional Med Ctr
New Orleans, Louisiana, 701122699
United States
Philadelphia FIGHT
Philadelphia, Pennsylvania, 19107
United States
North Jersey Community Research Initiative
Newark, New Jersey, 071032842
United States
Bronx-Lebanon Hosp Ctr
Bronx, New York, 10453
United States
Additional Information:
Study ID Numbers: CPCRA 064;
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005915
Other Hiv Infections Studies:
1. Safety of and Immune Response to a Combination HIV Vaccine Regimen in HIV Uninfected Adults
2. Study of Women Who Have AIDS
3. A Phase I/II Study of the Safety and Efficacy of Topical 1-(S)-(3-Hydroxy-2-phosphonylmethoxypropyl)cytosine Dihydrate (Cidofovir; HPMPC) in the Treatment of Refractory Mucocutaneous Herpes Simplex Disease in Patients With AIDS
4. Safety/Immunogenicity of Immunizations of ALVAC-DC-SC vs ALVAC-SC
5. Effects on the Immune System of Anti-HIV Drugs in Patients Recently Infected with HIV
Related Studies:
Other HIV Infections Clinical Trials
Other Virginia Clinical Trials
Other Richmond Clinical Trials
A Comparison of Two Anti-HIV Treatment Plans
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