A Study of the Long-Term Outcomes of HIV-Positive Patients
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00000932 |
Recruitment Status
:
Completed
First Posted
: August 31, 2001
Last Update Posted
: April 15, 2014
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
Condition or disease |
---|
HIV Infections |
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.]
Study Type : | Observational |
Actual Enrollment : | 3669 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | A Prospective Study of Long-Term Clinical, Virologic, and Immunologic Outcomes in HIV-Infected Individuals |
Study Start Date : | March 1999 |
Actual Primary Completion Date : | September 2006 |
Actual Study Completion Date : | September 2006 |

Group/Cohort |
---|
A
Participants currently enrolled in or currently being followed in an ongoing qualifying study. Qualifying studies can be found in the protocol.
|
B
Participants previously enrolled in but not currently being followed in a qualifying study. Qualifying studies can be found in the protocol.
|
C
Antiretroviral-naive participants not enrolling in a qualifying study (i.e., patients starting treatment outside the first study or patients deferring treatment)
|
- Clinical disease progression or death [ Time Frame: Throughout study ]
- Survival [ Time Frame: Throughout study ]
- Selected metabolic, hepatic, and cardiovascular conditions [ Time Frame: Throughout study ]
- Changes in viral load [ Time Frame: Throughout study ]
- Changes in CD4 count [ Time Frame: Throughout study ]
- Changes in HIV treatment methods [ Time Frame: Throughout study ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 13 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000932

Study Chair: | Jay Kostman | ||
Study Chair: | Roberta Luskin-Hawk |
Publications of Results:
Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000932 History of Changes |
Other Study ID Numbers: |
CPCRA 060 10110 ( Registry Identifier: DAIDS ES number ) |
First Posted: | August 31, 2001 Key Record Dates |
Last Update Posted: | April 15, 2014 |
Last Verified: | April 2014 |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Prospective Studies HIV-1 Drug Therapy, Combination Drug Resistance, Microbial CD4 Lymphocyte Count |
Disease Progression Treatment Outcome Genotype Anti-HIV Agents Viral Load |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |