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Home > "A" Clinical Trials Conditions > A Study of the Long-Term Outcomes of HIV-Positive Patients  A Study of the Long-Term Outcomes of HIV-Positive Patients
A Study of the Long-Term Outcomes of HIV-Positive Patients
For Condition: HIV Infections
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: The purpose of this study is to collect information about life spans and HIV-related illnesses in multiple groups of HIV-positive patients with varying anti-HIV treatment experience, including no treatment at all. Anti-HIV treatment has been successful in slowing disease progression in many patients. However, there are still questions regarding the best way to use anti-HIV drugs. This study is designed to provide long-term monitoring of patients who have already received anti-HIV treatment as well as patients who are just beginning treatment or have decided not to receive treatment.
Details: Highly active antiretroviral therapy (HAART) often results in short-term benefits for people with HIV in terms of reduced plasma viral levels and increased CD4 cell counts. When used at an early stage of HIV disease, however, the clinical benefit of HAART is uncertain. Many questions still remain regarding the optimal use of antiretroviral therapies, such as the timing of initial antiretroviral therapy and the composition of the best combination regimen to use initially or after virologic failure. Randomized trials of different starting antiretroviral regimens (e.g., FIRST [CPCRA 058]), different regimens after initial virologic failure (e.g., PIP [CPCRA 057]), and different management strategies for HIV infection (e.g., bis-POM [CPCRA 039], NvR [CPCRA 042], GART [CPCRA 046], and IL-2 VL/Dose [CPCRA 059] are being conducted by the CPCRA. [AS PER AMENDMENT 2/28/01: The MDR-HIV (CPCRA 064) protocol is now included as an example of a different management strategy for HIV infection, whereas the bis-POM (CPCRA 039) protocol is no longer included.] This study provides a mechanism for long-term monitoring of patients enrolled in these trials as well as antiretroviral-naive patients who are either starting treatment or electing to defer treatment. Patients are divided into 3 groups. Group A consists of patients currently enrolled in or currently being followed in an ongoing qualifying study (see Purpose for CPCRA trials which qualify). Group B consists of patients previously enrolled in but not currently being followed in a qualifying study. Group C consists of antiretroviral-naive patients not enrolling in a qualifying study (i.e., patients starting treatment outside the FIRST study or patients deferring treatment). Patients in Group A undergo monitoring of selected clinical and laboratory parameters (including plasma HIV RNA levels and CD4 cell counts) once every 4 weeks beginning after completion of all follow-up appointments for all other protocols in which they were enrolled. Patients in Groups B and C undergo monitoring of selected clinical and laboratory parameters (including plasma HIV RNA levels and CD4 cell counts) once every 4 months. Patients are followed for at least 5 years. [AS PER AMENDMENT 2/28/01: Patients who are not being followed in a qualifying protocol and are antiretroviral naive at enrollment or were previously enrolled in the FIRST (CPCRA 058) protocol undergo blood draws at enrollment and then annually for measurement of plasma HIV levels by a CPCRA-approved laboratory and future CPCRA-approved, HIV-related research. Patients who relocate to a non-CPCRA affiliated site are asked to sign a consent for ongoing release (every 4 months) of their medical records from their new health care provider to the CPCRA.]
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients may be eligible for this study if they: - Are 13 years of age or older (consent of parent or guardian required if under the age of 18). - Are HIV-positive. - Have either: (1) no previous experience with anti-HIV treatment (defined as no previous protease inhibitor or nonnucleoside reverse transcriptase inhibitor use, 1 week or less of lamivudine use, and 4 weeks or less of cumulative nucleoside reverse transcriptase inhibitor use) or (2) current or previous enrollment in a qualifying CPCRA study.
Total Enrollment: 3700
Location and Contact Information:
Overall Study Official:
JayKostman, Study Chair,
Denver CPCRA / Denver Public Hlth *Recruiting*
Denver, Colorado, 802044507
United States
Recruiting Jack Rouff 303-436-7184
Univ TX Health Science Ctr *Recruiting*
Houston, Texas, 77030
United States
Recruiting Hilda Cuervo 713-500-6751
Yale U / New Haven Med Ctr / AIDS Clinical Trials Unit *Recruiting*
New Haven, Connecticut, 065102483
United States
Recruiting Laurie Andrews 203-785-3557
Community Research Initiatives/ProACT *Recruiting*
Boston, Massachusetts, 02215
United States
Recruiting Sandy Sheble-Hall 617-778-5454
Petersburg Health Care Alliance *Recruiting*
Richmond, Virginia, 23298
United States
Recruiting Martha Howe 804-828-6471
Lawrence Goldyn, MD *Recruiting*
San Francisco, California, 94110
United States
Recruiting Carroll Child 415-476-9554
Philadelphia FIGHT *Suspended*
Philadelphia, Pennsylvania, 19107
United States
Suspended
Temple University School of Medicine *Recruiting*
Philadelphia, Pennsylvania, 19140
United States
Recruiting Kelly Lattanzi 215-707-8846
Henry Ford Hosp *Recruiting*
Detroit, Michigan, 48202
United States
Recruiting Diane Mastro-Polak 313-876-2798
Richmond AIDS Consortium / Div of Infect Diseases *No longer recruiting*
Richmond, Virginia, 232980049
United States
No longer recruiting
Harlem AIDS Treatment Grp / Harlem Hosp Ctr *Recruiting*
New York City, New York, 10037
United States
Recruiting Luis Fuentes 212-939-2957
AIDS Research Alliance - Chicago *Recruiting*
Chicago, Illinois, 60657
United States
Recruiting Rita Verheggen 773-244-5802
Washington Reg AIDS Prog / Dept of Infect Dis *No longer recruiting*
Washington D.C., District of Columbia, 20422
United States
No longer recruiting
Southern New Jersey AIDS Clinical Trials *Recruiting*
Camden, New Jersey, 08103
United States
Recruiting Carol Graeber 856-963-6890
Community Consortium / UCSF *Recruiting*
San Francisco, California, 94110
United States
Recruiting Carroll Child 415-476-9554
Vernon J. Harris East En Community Health Care Ct *Recruiting*
Richmond, Virginia, 23298
United States
Recruiting Marth Howe 804-828-6471
North Jersey Community Research Initiative *Recruiting*
Newark, New Jersey, 071032842
United States
Recruiting Robert Sawyer 973-483-3444
Community Research Initiative/ProACT *Recruiting*
Springfield, Massachusetts, 01107
United States
Recruiting Sandy Sheble-Hall 617-778-5454
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med *Recruiting*
New Orleans, Louisiana, 70112
United States
Recruiting Janice Walker 504-584-1971
Partners in Research / New Mexico *Recruiting*
Albuquerque, New Mexico, 87131
United States
Recruiting Cynthia Nicholson 505-272-6501
AIDS Research Consortium of Atlanta *No longer recruiting*
Atlanta, Georgia, 303081962
United States
No longer recruiting
Wayne State Univ - WSU/DMC / Univ Hlth Ctr *Recruiting*
Detroit, Michigan, 48201
United States
Recruiting Vickie Muhammad 313-993-0923
The Research and Education Group *Recruiting*
Portland, Oregon, 97210
United States
Recruiting Norma Martinez 503-229-8428
Additional Information:
Study ID Numbers: CPCRA 060;
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000932
Other Hiv Infections Studies:
1. A Study of Spiramycin in the Treatment of Patients with AIDS-Related Diarrhea
2. The Safety and Effectiveness of Didanosine Plus Stavudine Plus Delavirdine Mesylate Plus MKC-442 in HIV-Infected Patients Who Have Not Had Success with Protease Inhibitors
3. Safety and Effectiveness of Giving Two Nucleoside Reverse Transcriptase Inhibitors Alone or in Combination with 141W94 to HIV-Infected Children Who Have Never Received Protease Inhibitors
4. Retrovirus Epidemiology Donor Study I (REDS I)
5. A Phase II, Parallel Group, Randomized, Placebo-Controlled Study of the Safety and Efficacy of Thalidomide in Reducing Weight Loss in Adults With HIV Wasting Syndrome
Related Studies:
Other HIV Infections Clinical Trials
Other Pennsylvania Clinical Trials
Other Philadelphia Clinical Trials
A Study of the Long-Term Outcomes of HIV-Positive Patients
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