Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to see how HIV reacts in the immune systems of patients who have recently been infected with HIV. This study also examines HIV's resistance to anti-HIV drugs in newly infected patients.
Certain populations are good candidates for participation in HIV vaccine trials. These groups include men who have sex with men, IV drug users, and women at risk of getting HIV through heterosexual contact. Learning how HIV behaves in these populations once they become infected can help with the planning of future HIV vaccine studies.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | HIV-infected individuals enrolled in HIVNET D01 | ||
| B | Individuals with newly acquired HIV infection |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Detection of changes in HIV phenotype and genotype | Throughout study | |
| Clinical progression rates | Throughout study | |
| Antiviral resistance | Throughout study |
Not provided
Not provided
Inclusion Criteria
Patients must have:
Part A only:
Part B only:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions are excluded:
Prior Medication:
Excluded:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Celum C | Study Chair | |
| Buchbinder S | Study Chair | |
| Sheppard H | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles County / Health Research Assoc / Drew Med Ctr | Los Angeles | California | 90033 | United States | ||
Not provided
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D015819 | Substance Abuse, Intravenous |
| D018450 | Disease Progression |
| D018451 | Homosexuality, Male |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
Not provided
Not provided
Not provided
Not provided
Not provided
Specimens appropriate for clinical and laboratory assessments and necessary for evaluation of study outcome measures
| San Francisco Dept of Hlth / AIDS Office |
| San Francisco |
| California |
| 94102 |
| United States |
| Denver Dept of Public Health / HIVNET | Denver | Colorado | 80204 | United States |
| Univ of Illinois Chicago / Howard Brown Hlth Ctr | Chicago | Illinois | 60612 | United States |
| Johns Hopkins Univ | Baltimore | Maryland | 21205 | United States |
| Fenway Community Health Ctr / HIVNET | Boston | Massachusetts | 02115 | United States |
| New York Univ Med Ctr | New York | New York | 10016 | United States |
| Bronx-Lebanon Hosp Ctr | The Bronx | New York | 10453 | United States |
| New York Blood Ctr | The Bronx | New York | 10456 | United States |
| Univ of Pennsylvania / HIVNET | Philadelphia | Pennsylvania | 19104 | United States |
| Miriam Hosp | Providence | Rhode Island | 02906 | United States |
| Univ of Washington | Seattle | Washington | 98104 | United States |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006716 | Homosexuality |
| D019529 | Sexuality |
| D012725 | Sexual Behavior |
| D001519 | Behavior |