Infected Participants Protocol: Evaluation of Natural History of HIV Infection in Newly HIV-Infected Persons in HIVNET Target Populations
Data Collection
Collected from today forward - ProspectiveBlood-Borne Infections+24
+ Urogenital Diseases
+ Genital Diseases
Case-Only
Examining characteristics of individuals with a disease in order to identify genetic or environmental factors contributing to the condition.Summary
This study provides an opportunity to prospectively monitor markers of HIV infection and disease progression in cohorts suitable for HIV vaccine trials. The detection of changes in HIV phenotype and genotype, clinical progression rates, and antiretroviral resistance within study populations over time are important for planning future HIV vaccine trials. This study consists of two parts. Part A includes HIV-infected patients who enrolled in HIVNET D01.1 (infected-participants cohort of HIVNET D01) and whose HIV disease has been closely monitored and characterized. This study continues to monitor these patients with follow-up evaluations every 3 months for the first 18 months and then every 6 months thereafter. Part B includes newly HIV-infected patients. These patients are monitored with clinical and laboratory evaluations at 0, 1, 3, 6, 9, 12, and 18 months, and then every 6 months through Year 5.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Case-only
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria Patients must have: HIV infection, as documented by enrollment in HIVNET D01.1 (Part A patients) or by standard HIV serological tests or demonstrated HIV infection on virologic assay (Part B patients). Part A only: Previous enrollment in infected-participants cohort of HIVNET D01. Part B only: Initial HIV-seronegativity on an HIVNET protocol (other than an HIV vaccine protocol) and testing positive for HIV at a subsequent clinic visit. Confirmation of HIV infection and documentation of HIV negative antibody test within 8 months of first positive test. Exclusion Criteria Co-existing Condition: Patients with the following conditions are excluded: An obvious psychological/psychiatric disorder that would invalidate the informed consent process or otherwise contraindicate participation in the study. Prior Medication: Excluded: Participation in a HIVNET HIV vaccine trial.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 12 locations
Los Angeles County / Health Research Assoc / Drew Med Ctr
Los Angeles, United StatesOpen Los Angeles County / Health Research Assoc / Drew Med Ctr in Google MapsSan Francisco Dept of Hlth / AIDS Office
San Francisco, United StatesDenver Dept of Public Health / HIVNET
Denver, United StatesUniv of Illinois Chicago / Howard Brown Hlth Ctr
Chicago, United States