Clinical trial NCT00004998: Safety and Effectiveness of a New Anti-HIV Drug (AG1549) in Combination With Other Anti-HIV Drugs in HIV-Infected Patients
Official title: A Phase II, Open-Label Study of AG1549 in Combination With Other Antiretroviral Agents in Treatment-Naive HIV-Infected Patients
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE2
Conditions: HIV Infections
Keywords: Drug Therapy, Combination
Zidovudine
HIV Protease Inhibitors
Lamivudine
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Nelfinavir
Combivir
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if two different doses of AG1549 plus other anti-HIV drugs are safe and effective in HIV-infected patients who are not taking anti-HIV drugs.

Detailed description: \[Note: As of 2/28/2001, due to toxicity studies and concerns for safety, sites were notified that they need to discontinue patients from the capravirine/placebo arms and continue patients with their background therapies or switch patients to new therapies, as deemed appropriate by the investigators.\] Patients are randomized to receive one of two doses of AG1549 plus Viracept (nelfinavir) plus Combivir (zidovudine/lamivudine). Patients remain on their assigned therapy for 48 weeks, with a follow-up visit at 28 to 35 days after the last dose of study medication. Blood samples are taken regularly to quantify HIV-1 RNA, CD4 and CD8 counts, peripheral blood mononuclear cells (PBMC), AG1549, Viracept, and M8 plasma concentrations. Physical exams, safety assessments, and other tests are also done throughout the study. On Day 8 and at the end of Week 48, pharmacokinetic samples are collected at 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, and 12.0 hours postdose. At the end of Weeks 4, 8, 16, 24, and 36, pharmacokinetic samples are taken prior to dosing and between 2 to 4 hours post-dose.

Eligibility criteria: Inclusion Criteria

Patients may be eligible if they:

* Are HIV-positive.
* Are at least 18 years old.
* Have a CD4 cell count of more than 50 cells/mm3.
* Have an HIV level of more than 5000 copies/ml.

Exclusion Criteria

Patients will not be eligible if they:

* Have ever taken any of the following anti-HIV drugs: nonnucleoside reverse transcriptase inhibitors (NNRTIs), AG1549, Viracept, zidovudine, lamivudine, or Combivir. Other anti-HIV drugs are allowed only if taken for no more than 30 days with the last dose taken more than 6 months prior to study entry.
* Have taken an experimental drug within 28 days of study entry.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Clearwater
country: United States
facility: Clin Research of West Florida
state: Florida
city: Fort Lauderdale
country: United States
facility: Community Health Care
state: Florida
city: Miami
country: United States
facility: South Shore Hosp
state: Florida
city: Sarasota
country: United States
facility: Infectious Diseases Associates
state: Florida
city: Atlanta
country: United States
facility: AIDS Research Consortium of Atlanta
state: Georgia
city: Boston
country: United States
facility: Beth Israel Deaconess Med Ctr
state: Massachusetts
city: Jamaica
country: United States
facility: Catholic Med Ctr
state: New York
city: New York
country: United States
facility: Liberty Medical
state: New York
city: Pittsburgh
country: United States
facility: Anderson Clinical Research
state: Pennsylvania
city: Santo Domingo
country: Dominican Republic
facility: Immunity Care and Research Inc
Study officials:
References: